Research Consent and Authorization Helix Research Network( HRN)
OR REVIEW ONLY
IRB APPROVED May 19, 2025
have an impact on your health. There is also a chance that information you learn could impact the health of your family members. Most people will not learn information from the study that will immediately impact their or their family’ s health care.
Will I be paid to take part in the research? You will not be paid to participate in the study. We may use your samples and information to develop new products or medical tests to be sold. Helix and Renown Health may benefit if this happens. There are no plans to pay you if your samples are used for this purpose.
It is possible that researchers and their organizations may potentially benefit from the sharing of the information or sale from the discoveries they make. You will not have any financial or other rights to these discoveries.
Does it cost me anything to participate in the study? There is no cost to you or to your insurance company for being a part of this study.
If the Helix Health CDCT1 Screening Test finds that you have a clinically actionable result, you will be able to speak with a genetic counselor at no charge to you. Any other medical appointments or testing you pursue will be billed to you and / or your health insurance provider. For example, if a test result shows that you may have an increased chance of getting cancer, then your healthcare provider may want you to have earlier or more frequent screening. The cost of screening may be covered by your health insurance or, if your health insurance policy does not cover them, you will have to pay for the screenings.
Do the researchers have monetary interests tied to this study? It is possible that certain researchers, or the institutions taking part in this study, may have a financial interest in the outcome of this study. This means that Helix, the sponsor of this study, and the institutions participating in the study may receive payments based on the success of this research project.
However, Helix and the researchers and institutions who participate in the research network are committed to conducting research with integrity and without bias. If you have any questions about this, please contact the principal investigator or Renown Health.
How will you protect my privacy and confidentiality? Your privacy is very important to us, and we take many steps to protect it. Here are some of the steps we will take:
● Your samples will be stored in a secure biobank by Helix or Renown Health.
● Your information( your genetic information and your medical record information) will be stored in secure databases.
● Your genetic information and your medical record information will be assigned a unique code before the information is transferred to the Helix Research Network Database.
● We will limit and keep track of who can see this information.
● We will limit who is allowed to see information that could identify you, like your name or contact information.
● Researchers who have access to your information must be trained to work with this type of information.
● Researchers must agree to follow certain rules, like agreeing to not re-identify you.
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