NorthShore



Genomic Health InitiativePablo Gejman, MDhttp://northshore.org/ghiNorthShore Medical Group & NIHWe are asking you to enroll in the study since you are an adult NorthShore patient. If you decide to participate, we will collect, process, and store your extracted electronic health record data and samples, along with data and samples from many other volunteers. We (Genomic Health Initiative) will carry out research on these samples and data.Our broad objective is the promotion of health at NorthShore and for society as a whole. Specifically, we plan to achieve this through genomics research. Human genomics is the study of genes and their functions at the level of cells up to the whole human organism, as well as how genomic abnormalities cause or predispose to disease. Our goals are: 1- Identification of genetic risk factors to enable reduction of risk for common adulthood diseases. These disease risks can then be minimized by approaches such as diet, lifestyle, or other environmental modifications. 2- Detection of genetic risk factors before clinical diagnosis becomes feasible. This will enable preventive or earlier treatment interventions. 3- Development of new treatment interventions. As the biology of a disease becomes better known, researchers can find potential new targets for treatment interventions. We are planning to enroll thousands of participants over the next several years. We hope you will participate.Adult patients at NorthShore10000010,000You are asked to donate three small extra tubes of blood, less than one tablespoon in total, exclusively for research use. This blood will be collected at your visit to any of NorthShore's hospital outpatient labs or patient service centers -- please refer to www.northshore.org/lab-services/locations for a list of these designated laboratories and their locations. This can be at an already scheduled clinical blood draw, without needing an extra needle stick, or you may instead request a research blood draw at any time. You are also asked to allow the use of future leftover biological samples, such as urine or blood, for research. These are clinically unused leftover samples from your laboratory tests that would normally be discarded. This does not require any action from you, such as a separate sample collection or for you to be recontacted. We will study your donated samples now and in the future. All samples are stored in secured freezers at NorthShore, and these samples will be labeled with a unique research code instead of your name or other identifying information. From time to time we will update the research database with information from your electronic health record, such as demographic information, medical history, test results, medical procedures, images (such as X-rays), medicines you take, and other information in your electronic health record. Some of this clinical information could be considered sensitive, such as various diagnoses, behaviors, and conditions.You are asked to donate three small extra tubes of blood, less than one tablespoon in total, exclusively for research use. You are also asked to allow the use of future leftover biological samples, such as urine or blood, for research. These are clinically unused leftover samples from your laboratory tests that would normally be discarded. This does not require any action from you, such as a separate sample collection or for you to be recontacted. We will study your donated samples now and in the future. All samples are stored in secured freezers at NorthShore, and these samples will be labeled with a unique research code instead of your name or other identifying information. From time to time we will update the research database with information from your electronic health record, such as demographic information, medical history, test results, medical procedures, images (such as X-rays), medicines you take, and other information in your electronic health record. Some of this clinical information could be considered sensitive, such as various diagnoses, behaviors, and conditions.From time to time we will update the research database with information from your electronic health record, such as demographic information, medical history, test results, medical procedures, images (such as X-rays), medicines you take, and other information in your electronic health record. Some of this clinical information could be considered sensitive, such as various diagnoses, behaviors, and conditions.The NorthShore research staff involved in this Genomic Health Initiative, the NorthShore Institutional Review Board (IRB) that oversees the research, and US agencies that oversee or review research, such as the National Institutes of Health. By agreeing to participate in this study you are authorizing the Genomic Health Initiative researchers to use your PHI identifiers. Your PHI identifiers will only be used for the purposes described in this Consent FormIndefiniteYour genetic research results will not become part of your electronic health record. Though we will not give you raw data from research done using your sample, you will be able to get news about general research findings from studies done and publications on the Genomic Health Initiative website (northshore.org/ghi). This study website will also have information about ongoing studies on the Genomic Health Initiative sample, which you can review in case you might have specific interests or concerns. Please also note the re-contacting section at the end of this consent form regarding suggestions for potential follow-up clinical testing.Opt inVoluntaryOpt in for future contactYour privacy is very important to us, and we will make every effort to protect it. Information you provide will be recorded in the research database at NorthShore. All identifiable computer records will be maintained on an internal network that is not accessible from the Internet. Access to this research database is restricted to study- associated personnel.http://www.northshore.org/globalassets/personalized-medicine/eh14-092-cf-hipaa-stamped_forwebsite-6.21.16.pdfILUSA