Research Consent and Authorization Helix Research Network( HRN)
OR REVIEW ONLY
IRB APPROVED
Results from these additional tests will be returned to your medical record and to your healthcare provider.
There will be no charge to you for these additional tests.
May 19, 2025
Are there any additional risks to this sub-study? 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.
Liver Imaging( Hepatoscope): There is a small physical risk that you may be allergic to the gel used while performing this imaging, which could lead to discomfort and minor skin irritation. Due to the limited and defined scope of this imaging test, operators will not be performing surveillance of the liver and therefore will not be able to report on findings outside their trained scope of knowledge.
What happens if I become sick or injured because I took part in the sub-study? If you think you may have been injured due to your participation in this sub-study, you should tell the Principal Investigator about it as soon as possible.
Your healthcare provider will offer you the care needed to treat injuries directly resulting from taking part in research. These treatments will be billed to you or your insurance company. You will be responsible for any payments from this treatment, including co-pays or deductibles. There are no plans to give you compensation for any injuries.
Gilead Sciences Inc, the sponsor of this sub-study, has not set aside any money to pay for research-related injuries or treatments. You do not give up any of your legal rights by signing this form.
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