Research Consent and Authorization Helix Research Network( HRN)
OR REVIEW ONLY
IRB APPROVED May 19, 2025
You may receive these results in two ways:
● First, these results will be returned to your medical record. You cannot opt out of having your DNA health results placed in your medical record. Once this information is in your medical record it cannot be removed even if you withdraw from the research study.
● Second, you will also be able to access these results through your Helix Account, if you choose to create one. There may be a delay between when your results are available in your medical record and when you are able to access them through your Helix account.
If your test reveals a positive( or clinically actionable) result for any of the three conditions above, the study team will reach out to you, and you will have the opportunity to speak with a genetic counselor at no charge to you. A genetic counselor is a medical professional specifically trained to help you understand how your genetic information may impact your health and the health of your family members, discuss medical recommendations, and discuss how you can approach sharing any important information with others. An initial discussion between you and a genetic counselor will be coordinated by Helix and Renown Health.
You may also want to do further independent testing and speak with your healthcare provider( or any healthcare provider) about the results of this test, and whether additional or different genetic testing and general screening may be appropriate for you. In addition, if you have a personal or family history of a condition covered by this test, it is important to know the results of this test do not change a previous diagnosis or any family history risk you might have. Results from this research study do not take the place of regular screening guidelines such as colonoscopies or mammograms.
In rare circumstances the interpretation of the results you receive may change. This may be due to updates to what is known about a genetic variant you may carry that may change how it is understood to affect your risk for one of the listed conditions. If new information becomes available and your report is updated, you will be contacted by the study team to discuss what this may mean for you. The vast majority of people will not see any change in their initial results.
Over time, more health-related results may be returned to you as researchers and clinicians learn more about how DNA impacts human health.
What is a Helix account and what other results may I get? When you agree to participate in this study you will have the option to create a personal account with Helix( the laboratory and research sponsor). This account will allow you to:
● Access easy-to-understand information about your DNA, including information about your ancestry and non-medical traits( such as how you process caffeine and what type of ear wax you have).
● Receive updates or questions directly from Helix. Updates might include new discoveries from the research, stories of other participants, and stories about researchers.
Creating a Helix account is the only way to access the results from your ancestry and nonmedical traits. Your ancestry and non-medical traits will not be placed in your medical record.
The results about ancestry and traits will be available for you to review before your DNA health results are available. Your DNA health results will take longer because they go through additional quality and scientific review.
Version 7, 02 / 17 / 2025 Page 7 of 18 Renown V2, 05 / 07 / 2025