Marshfield Clinics

Personalized Medicine Research ProjectWarner Slack, MD 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. 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.PMRP participants are 18 years of age or olderUnlimited20,000All persons enrolled in PMRP are asked to fill out a questionnaire that requests data on race/ethnicity, education, smoking, alcohol use, family history of chronic disease, and employment. Participants are also asked to complete self-administered food frequency and physical activity questionnaires. The percentage of participants who have completed these questionnaires is approximately 68%. Blood is also drawn from participants for extraction of DNA and processing of serum and plasma. The blood is processed within 24 hours of collection and the DNA, serum, and plasma are stored at -80oC. Participants are not required to fast before their blood is drawn but they are asked to provide the time since their last meal. The physical activity questionnaire used in the PMRP is the Atherosclerosis Risk in Communities (ARIC)/Baecke Questionnaire. It is a modified version of the original Baecke Questionnaire; The modified version comprises 16 questions about physical activity at work, while playing sports, and during leisure time. The modified questionnaire has previously been validated with physiological methods.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.We anticipate that both external and internal investigators will request access to data and biological samples from the Personalized Medicine Research Project (PMRP). It is important to read the information contained in the Data and Tissue Access Guidelines to understand the process for obtaining access to PMRP data and samples.All proposals for use of PMRP biological samples will be reviewed by a PMRP Oversight Committee that grants final approval for requests to use PMRP DNA, plasma, or serum samples. All investigators are expected to return data from assay of biological samples to the PMRP database for other investigators to use. The return of data should occur within six months after final data analysis. All investigators requesting PMRP data and/or samples should include funding in their budget for the following items, where relevant: Time and effort of Information Systems programmers to create a list of study subjects or study datasets. Time and effort for manual abstraction of electronic medical records. Time and effort for Information Systems programmers to return assay data to the PMRP databaseWe will continue to add to the research database indefinitely. This will allow the researchers to follow the health of a large group of people in Central Wisconsin.We will not share individual results with you. Research results are often just the first step in answering questions about a disease. They often have not yet been proven. Because of this they cannot help in making decisions about patient care and treatment. Researchers will send a newsletter up to 4 times a year. The newsletter will not contain individual results. It will have general information about studies. It may provide general information about discoveries from the project. If you wish to get this newsletter by email, please provide your email address hereThis project will last many years. We will need to update questionnaire information. We may need to recontact you if we are studying a specific illness or condition that you may happen to have. If you are recontacted, it would not mean that anything has been learned specifically about you. Everyone in the study should expect to be re-contacted at some point over the life of the project. Your DNA, plasma and serum will be saved for as long as possible. Over time, samples may be used up or lose quality. Researchers may re-contact you for another blood sample if this occurs. We may need to have samples collected over time to see what changes may be occurring.We have a Certificate of Confidentiality from the National Institutes of Health. This helps us to protect your privacy. Researchers can not be forced to give out information that could identify you in any court matter. While not likely, government officials could try to use this information. The Certificate has not been tested in courts. This Certificate will not prevent necessary auditing or evaluation. We would still need to disclose information that is required by the Food and Drug Administration (FDA). We will code all information entered into the database. We will not use your name, date of birth, phone, medical history or social security number as part of this code. Project staff that sees your medical record information will not be able to see genetic information. People we share research data with will see only coded information. They will not be able to identify you. There is a federal law called the HIPAA Privacy Rule. It requires us to keep your medical information private and confidential. Some researchers we share information with may not be required to follow this federal law. In Wisconsin there is a state law that requires us to keep medical information confidential. We may share information with researchers in states with different state laws. While we work with other researchers that are very professional and are also concerned about confidentiality, we cannot guarantee they are required to follow the same rules.VoluntaryHaving blood taken from a vein may result in minor pain and slight bruising. There is a small chance of infection at the site where the blood was drawn. Some people might faint when their blood is drawn. There is a very small chance your personal information could become known to you, your doctor, or others. If research results are released by mistake it may cause you some distress. You could be treated differently. It may cause psychological or social problems for you. This information could also affect family relationships. These risks are very low because we are careful about protecting research information. This consent form describes the known risks of research in which DNA samples are used. There may also be risks we have not foreseen.Neither you nor your insurance company will get a billed for study- related procedures.All samples, data and research findings will belong to The Marshfield Clinic. However, we may work with other institutions or companies to develop commercial products, patents or licenses. If these are developed, there are no plans to share profits with you. We will put any profits back into the Marshfield Clinic system. We will use the money for healthcare, education and research.You have the right to withdraw from this study at any time. If you withdraw, we will destroy your remaining DNA, plasma and serum. We will not use your information in future studies. If your samples have already been used in research it would not be possible to remove any of the information that may have been learned prior to your request to withdraw. We will document your decision on a form, and ask you to sign the form. If you wish to withdraw please call us at 715-389-7733 or 1-888-334-2232.