Research Consent and Authorization Helix Research Network( HRN)
OR REVIEW ONLY
IRB APPROVED May 19, 2025
Please note: The results of your ancestry and traits may be different from what you understand to be true about yourself. It is important to understand that trait and ancestry results are estimates based on DNA patterns rather than definitive information. This is different from Helix Health CDCT1 Screening Test testing that looks for the presence or absence of specific genetic variants. Such variants have extensive evidence from the medical community linking them to risk for disease.
What are the possible risks of participating in this study? There are risks to participating in any research study. Some of the more commonly known risks are described below. Taking part in the study, including use of your information in the Helix Research Network, may have additional risks that we don’ t know about yet. We will tell you if we learn anything that might change your decision to take part in the study.
Loss of Confidentiality / Privacy: The main risk of participating in this study is to your privacy. Both Helix and Renown Health take many steps to protect the confidentiality of your information, but as with any research study, we cannot guarantee that your identity will never become known. Information about you that does not directly identify you, including genetic information, may be placed into public databases where the information might be capable of re-identification if combined with other data sources. Through such databases, researchers from around the world would have access to your data for future research. There is a risk that researchers may connect information from this study to your personal information, even if the study data does not contain directly identifying information about you. Although your genetic information is unique to you, you do share some genetic information with your children, parents, brothers, sisters, and other blood relatives. As a result, it may be possible that genetic information from you could be used to identify them.
While the databases developed for this study will have processes in place to keep information secure, there is always a chance that a data breach might occur. This is when someone who does not have permission accesses your information. While the risk of someone misusing your information is very low, there is still a possibility.
Sample Collection: There is a small physical risk if you give a blood sample. The most common risks are brief pain and bruising. There is also a small risk of infection. Some people may feel dizzy or rarely faint. There are no known risks to providing a saliva sample, urine sample or cheek swab.
DNA Results: Medical information created by this research study, such as genetic findings that may be important for your health care, may become part of your hospital medical record and may be forwarded to your healthcare provider. Even though the results may help in making clinical decisions, there ' s a risk that they could be inaccurate. This could lead to wrong treatments or missed diagnoses, and may cause you to experience anxiety or concern, potentially affecting your health or the health of your family members. You might consider getting additional independent testing, consulting with your doctor, or using the professional genetic counseling provided by the sponsor of this study.
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