Geisinger



MyCodeDH Ledbetter, PhD.http://www.geisinger.org/for-researchers/partnering-with-patients/pages/mycode-health-initiative.htmlRegeneron500,00098,323Protected health information (PHI) is information about your health or your medical care that was collected by a healthcare provider (like Geisinger) that can be used to identify you. Federal and state laws are in place to protect your PHI. Geisinger has departments that are responsible for making sure researchers follow these and other laws. Staff members in these departments may look at your research records to make sure we are following these laws. Your PHI may be shared if it is required by law. Regulatory organizations may inspect and/or copy your research records (including information in your medical record) for quality assurance. These organizations include the U.S. Food and Drug Administration and the U.S. Department of Health and Human Services. These organizations must follow federal laws to protect your privacy when we are required to share your information. The chance that Geisinger will be required to share your PHI with these agencies is small. If your PHI is shared outside of Geisinger, then some federal privacy laws may not apply. Some of these laws only apply to hospitals, doctors’ offices, and other healthcare providers. Geisinger will make every effort to protect your PHI, but we cannot absolutely guarantee that your information will be safe. Some genetic information that is uncovered by studying your DNA is unique to you (like fingerprints). When your genetic information is shared, we will make every effort to protect it. Researchers will promise not to try to identify you using any information they are given. The chance of anyone identifying you is small.There is no planned end date for MyCode. Your samples and information will be kept until they are no longerIf we find information that we think you should know to help your medical care, then we will: x Tell you about the research result and what it means for your health; x Tell your healthcare provider; x Put this information in your medical record; and x Work with you to make sure that you understand what you should do about this information Information about your increased chances for a health problem may be important for your parents, your children, and/or your siblings. If you give us permission to contact your family, then the MyCode team will work with you to make sure that your family members also benefit from this information. If your family members are not Geisinger patients, then we will help them contact genetic professionals near where they live who can help them. You and your family members will: x Get information that tells you what we found in your sample x Get information that explains why you have a higher chance of having a health problem x Be able to call or email licensed genetic counselors who can give you more information The initial information and support Geisinger gives you will be free of charge. Any appointments or testing that you choose to have done because of your increased chance will be billed to you and/or your health insurance provider.VoluntaryThere are no risks involved in giving a saliva sample. If you give a blood sample for MyCode there is a small risk of bleeding, bruising, infection at the needle site, or fainting (this is rare). If we tell you that you have a higher chance of having a health problem because of something we discover from studying your sample, then there is a risk that you might be surprised or upset. There is a chance that your MyCode samples and information may be shared or used inappropriately. Geisinger takes the protection of your privacy very seriously and works hard to keep your information safe. We cannot guarantee that your information will be kept private. We think the risk of your information being shared or used inappropriately is small. We also do not know every possible risk that might come up in the future.In most cases, researchers do not need information that could identify you when they are doing research using your MyCode samples and data. Your samples and research data will be given a special code or study identification (ID) number. These ID numbers will be used to label samples and data when they are used for research, instead of information like your name or birth date that could be used to identify you. Information that links you to your ID number will be kept in a secure file that is protected by Geisinger. Only a few people on the MyCode team will have access to this file. All of these people have been trained to protect your information. Information that can identify you will be given to Geisinger researchers only when it is necessary for the research, and with the approval of the Geisinger Institutional Review Board and the MyCode Governing Board. If a non-Geisinger researcher wants information that identifies you, then a member of the MyCode team will contact you to see if you want to learn more about the study the researcher is doing. If you agree to learn more about their study, then the MyCode team will give the researcher your contact information. Then the researcher will contact you to tell you more about their study. You have the right to decide whether or not: x You want to learn more about their study; x You want to take part in their study. All researchers who use MyCode samples or information are required to protect your privacy. We will not tell you every time your samples and/or information are used for research projects.The main benefit of being a part of MyCode is helping researchers learn more about human health and disease. This will lead to better ways to treat disease and keep people healthy. There is a chance that researchers might find information that could be important to your health (and the health of your family members) when they study your MyCode samples. Based on what we know today, we will find information that will be useful for medical care in only about 2% (1 in 50) of MyCode participants. The chance of finding information important to your health will increase as we learn more about health and disease. Geisinger has a team of experts who will decide what research results should be given to MyCode participants and how we should tell them. Examples of such research results are increased risk of developing serious diseases like heart disease or cancer or how a person might respond to a medicine. We will only inform you when we find information that we believe can be helpful in your medical care. At this time we will not tell you about health problems for which there are no medical treatments (like Alzheimer’s disease or Huntington’s disease). Geisinger is committed to helping you understand and use the information that we might return to you as a result of your participation in MyCode. Research that uses your samples and information may not be finished quickly. There is a chance that you will not hear from any researchers. If you do not hear from anyone on the MyCode team: x Your sample may not have been studied yet OR x You may not have any of the gene changes that we are studying at this timeBeing a part of this project is your choice. If you decide to participate now, but change your mind at any time later, then you can then withdraw from MyCode. Your decision will have no effect on the medical care you receive from Geisinger. If you wish to stop and no longer participate in MyCode, please write or call us using the contact information below. If you choose to call, we will send you a form to sign and return to us to complete the withdrawal process. If you choose to stop being a part of MyCode we will not collect any new samples or information from you. Your samples in the MyCode biobank will be destroyed. If your information has been shared with researchers, then these researchers may keep using the information they have for research. You will not own any information, medical tests, medicines, or other products that are created from research that used samples and information from MyCode. You will not get any of these products for free or get any money or other payment from the sale of any such product(s). For questions about your rights as a research participant, please contact the Geisinger Institutional Review Board at 570-271-8663. When you call them, please give them the study number 2006-0258.There is no extra cost to you or to your insurance company for being a part of MyCode. If you are one of the people who get information from MyCode about your health, then medical appointments or testing you choose to have done because of this information will be billed to you and/or your health insurance provider. For example, if we find that you have an increased chance of getting breast cancer, then your doctor may want you to have mammograms more often than most women. The cost of these mammograms may be covered by your health insurance policy or you may have to pay for them.http://www.geisinger.org/for-researchers/partnering-with-patients/includes/pdf/MyCode-Consent-V28.pdfhttp://www.nature.com/gim/journal/vaop/ncurrent/full/gim2015187a.htmlPNUSA