Research Consent and Authorization Helix Research Network( HRN)
OR REVIEW ONLY
IRB APPROVED May 19, 2025
If you have questions about your rights as a research participant or questions, concerns or complaints about the study that you do not want to talk about to the study staff, you can contact WCG IRB, an Institutional Review Board( IRB). The purpose of the IRB is to review studies to ensure your rights as a research participant are protected:
WCG IRB 855-818-2289 or clientcare @ wcgclinical. com
Optional Sub-study Opportunity for M / NASH Patients You are being asked to participate in an optional sub-study. By signing this consent form, you are agreeing to allow the HNP study team to contact you, if you are eligible, regarding the additional sub-study testing.
If you decide to perform the additional testing, your additional participation is outlined below.
If you decide not to perform the additional testing, you can still participate in the main research study. Please take your time to make your decision and discuss it with your family and friends.
What is this sub-study and how is it different from the HNP study? As a part of the Healthy Nevada Project, Renown is running a large-scale sub-study looking at the genetics of a liver disease called Metabolic and Non-alcoholic Steatohepatitis( M / NASH).
Due to this sub-study, you may be eligible to receive additional testing to assess your risk of liver fibrosis( liver scarring). Liver fibrosis could lead to significant liver disease( even if you don ' t consume alcohol).
To be eligible for this blood draw, the requirement is to stop taking vitamins or supplements that contain biotin 3 days prior to your blood collection appointment. To be eligible for the liver stiffness imaging test, no additional requirements are necessary.
If you decide to participate in this optional sub-study, we will use, share and protect your data as outlined above. You have the right to withdraw from the sub-study using the same process described above.
Who is paying for this sub-study? Gilead Sciences, Inc is sponsoring this sub-study.
What happens during the sub-study, what am I being asked to do, and will it cost me anything? If you are found to be eligible Renown Health may request an additional sample from you to measure your complete blood counts( CBC), a liver function test, and / or an Enhanced Liver Fibrosis( ELF) test.
Some participants may also be asked to have an imaging test performed, such as a hepatascope, that checks the liver for fibrosis. This test is performed using ultrasound, and is a completely non-invasive, painless procedure that takes approximately 10 minutes to complete. The results of any such test would be entered into your medical record and used as part of the dataset for this study.
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