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Murdock Studyhttp://www.murdock-study.com/Duke University12,00012,000Researchers who study your samples and information will not know who you are. We will give them only a code number and not any information that directly identifies you. The researchers must promise they will not try to find out who you are. They must also promise to keep the coded materials secure.Data and samples in this repository will be maintained indefinitely. This study has a long-range goal to identify factors that contribute to many diseases and illnesses. No end date has been set for analyzing results from the study. As new information about diseases becomes available and new methods of analyzing research results are developed, we hope to use the samples and data over time to continue to advance knowledge about many diseases.Research records are separate from medical records. We will not place any information that we get or create as part of this project in your medical record. RESEARCH RESULTS. You should not expect to get individual results from research done using your samples and information. Researchers must study materials from many people over many years before they can know if the results have meaning. The results will not affect your care right now. They will not be given to your doctor and will not be put in your medical record. You can get general news about the kinds of studies being done through the MURDOCK Study at www.murdockstudy.org and a quarterly newsletter that you will receive if you join the MURDOCK Study. INCIDENTAL FINDINGS. There is a small chance that researchers could learn something about your health that you and your doctor did not know before. For example, they might find that you have a condition not previously diagnosed. Or they might find that you have a gene or other risk factor that is known to increase the chance you or a member of your family could get a disease in the future. We will offer to tell you a finding like this only if it is about a serious disease for which a treatment is available. We will send a letter by certified mail asking you to contact Dr. L. Kristin Newby and Dr. Rowena Dolor. Drs. Newby and Dolor will arrange a time for you to meet with them or another health care provider to go over the information. Notification will be sent to the last address you provided to us. Therefore it is important that you inform us of any change in your address. At that time, if you would prefer not to receive the results, you will be asked to inform Dr. Newby or Dr. Dolor of your preference. The staff will not release these specific research findings over the telephone or in the mail.Researchers may contact you in the future with offers to take part in other research. We will not notify you every time your samples and information are used in a study. However, some researchers might apply to do a study for which they would need to contact you. For example, they might want to ask you to fill out a survey, do a phone interview, or be seen by a researcher or doctor. If a study like this is approved, the researcher will contact you to tell you more about the study. There will be a new consent process just for that study. You can decide then to take part or not take part. If you do take part, your samples and information from these additional studies will be added to the MURDOCK Study Biorepository and may be used for future research. We will make sure researchers do not contact you about more than four studies like this per yearPhysical Risks. Like any other time you have blood drawn, you may feel brief pain or have some bruising from the needle. Infection, excess bleeding, clotting or fainting is also possible, but unlikely. Privacy Risks. There is a risk that someone could get access to the data we have stored about you. If those data suggested something serious about your health, it could be misused. For example, it could be used to make it harder for you to get or keep a job or insurance. There are laws against this kind of misuse, but they may not give full protection. We believe the chance of these things ever happening is very small, but we cannot make guarantees. Your privacy and the confidentiality of your data are very important to us and we will make every effort to protect them. These efforts are described in the part below called “How Will Information About Me Be Kept Confidential?” Potential Risks and the Genetic Information Non-Discrimination Act (GINA): There is a potential risk of loss of confidentiality. Every effort will be made to protect your confidential information, but this cannot be guaranteed. The genetic information obtained as a result of your participation in this research will not be included in your medical record. Information from which you may be personally identified will be maintained in a confidential, secure location at DUHS, accessible only by authorized members of the study team, and will not be disclosed to third parties except as described in this consent form, with your permission, or as may be required by law.Federal privacy rules give safeguards for privacy, security, and authorized access. We will not give information that identifies you (name, social security number, address, telephone number, or any other direct personal identifier in study records) to anyone without your permission. We will remove your name and anything that could directly identify you from your samples and replace them with a barcode. These samples will be kept in locked freezers in locked buildings. We will keep the master list that links the code number to your name on secure computers. We will keep health information and research data on secure computers with very limited access. These computers have many levels of password protection. Only a few of the MURDOCK Study staff will have access to the data and all MURDOCK Study staff sign a pledge to keep your identity a secret.You will most likely not benefit directly if you decide to take part in this project. The main reason you may want to take part is to help researchers make discoveries that might benefit people in the future.There are no costs to you or your insurance for taking part in the MURDOCK Study Biorepository. We will give you a $10 gift card to pay you for the time it took for you to join the Study.Your samples and information will be used only for research. You should know that research sometimes leads to discoveries that may one day have commercial value. For example, research could lead to new tests, drugs, or other medical products. If you take part in this project, that means you agree to let the MURDOCK Study make your samples and information available for these uses. In the event that research using samples and information stored in the Biorepository leads to a product that could be sold commercially, there are no plans for you to share in any profits. Development of new products usually relies on the study of samples and information from hundreds or thousands of people, not on any one person. The Duke University Health System and/or the developers will assert all rights of ownership in the samples and information, as well as all rights arising from use of the samples and information.If you agree to take part in the MURDOCK Study, you are free to change your mind at any time. If you change your mind, please contact the MURDOCK Study office at (704) 250-5861 or (877) 673-2508 and let us know. At that time, we will ask you to indicate in writing on an official MURDOCK Study participant withdrawal form if you want unused blood and urine destroyed or if your samples (having all identifying information that would link the samples to you removed) could be used for further research. Please note that if we have already distributed some of your samples and information for the Study, we cannot call them back. Also, we cannot destroy knowledge already gained from the study of samples and information. But if you change your mind, you can tell us not to give researchers your materials for any more studies.9/24/2014http://murdock-study.com/wp-content/uploads/2014/10/Consent-Form.pdfhttp://journals.plos.org/plosone/article?id=10.1371/journal.pone.0013302NCUSA