Research Consent and Authorization Helix Research Network( HRN)
OR REVIEW ONLY
IRB APPROVED May 19, 2025
products. If you choose to provide a blood sample, we will collect approximately 5 mL( about one teaspoon) of blood in a single draw. Unless this sample fails quality checks, you will not have any additional blood taken.
● If you plan to provide a saliva / cheek swab sample, please make sure you do not eat, drink, smoke, chew gum, or brush your teeth for 30 minutes beforehand
● If you use the at-home kits, you will be instructed how to send your sample to our sequencing partner and one of the sponsors of this study, Helix. Your sample will be linked to information that identifies you, like your name and date of birth, when it is sent.
● Helix is a clinical laboratory and population genomics company that will sequence the DNA in your sample. DNA sequencing is a process that is used to read your DNA.
● Helix will securely store your genetic information after sequencing your DNA and ensure it is correctly linked to you. We will study your DNA using whole exome or whole genome sequencing. Whole exome sequencing is a way of studying your genes, the parts of your DNA that tell your body how to function. Whole genome sequencing is a way of studying all the parts of your DNA, including the DNA in between genes. Because this study will last for many years, it is possible that some of the methods we will use to study DNA may not have been invented yet.
○ If Helix tested your DNA before you agreed to join this study, you may be able to contribute your genetic information to the study without providing an additional saliva sample.
○ In the future, if your healthcare provider orders a DNA test to help inform your healthcare, your provider may have the option to use the genetic information that was generated as part of your participation in the Helix Research Network that is stored by Helix to perform additional clinical tests, if you agree that your provider may do so. This means you would not need to submit another sample for testing, and it means you may receive test results more quickly. If your healthcare provider orders this type of test( called a clinical or diagnostic test), they will ask you for your consent to the test and use of your genetic information at that time. Any future clinical or diagnostic test would be separate from this research study and would be billed to you or your insurance. You always have the right to choose where you obtain healthcare services and determine how your genetic information is used for future clinical and diagnostic testing. Nothing in this consent form is intended to require or obligate you to agree to clinical reuse of the genetic information stored for you by Helix or to seek care from Renown Health or a particular healthcare provider.
● Share your medical record information with Helix for research purposes on an ongoing basis. This information might include diseases or symptoms you have, results of medical tests, and medicines you are prescribed. To protect your privacy, before the information is added to the Helix Research Network Database, information that directly identifies you( such as your name) will be removed and replaced with a code. Helix will use this code, instead of your name, to combine your medical record information with your genetic information and store it securely in the Helix Research Network Database.
● Ask you questions about your health and your experiences using surveys or other data collection tools. Participating in follow-up surveys or additional data collection activities is optional.
● Tell you about results we get from studying your samples and information that might be important for your health and health care decisions.
● Helix or Renown Health may request additional samples from you, like blood or urine, or cheek swab, or collect samples that were collected for clinical testing and are left over
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