Research Consent and Authorization Helix Research Network( HRN)
OR REVIEW ONLY
IRB APPROVED May 19, 2025
● We will tell you if we become aware of a data breach that impacts your information.
● All researchers go through an approval process before gaining access to your information. The lead researcher for the study( the Principal Investigator) will participate in a committee that includes researchers from other health systems that do similar research. This committee is responsible for setting standards for access to your information.
● Researchers plan to publish the results of their research. As part of the publication process, researchers may be asked to make certain information available to other researchers. We will not include information that directly identifies you in any publications.
Your identity will be kept as confidential as possible as permitted within the law. However, people from Helix, regulatory authorities( including the United States Food and Drug Administration), and the Institutional Review Board( who protects the rights of research participants) have the right to inspect study records, including identifiable information about you, to verify the compliance of study procedures and data.
A description of this clinical trial will be available on http:// www. ClinicalTrials. gov, as required by U. S. Law. This Web site will not include information that can identify you. At most, the Web site will include a summary of the results. You can search this Web site at any time.
Do I have to participate in the study and what are my alternatives? No, participation in this study is completely voluntary. Whether or not you choose to participate, it will not impact the care you receive at Renown Health or any of its study partners. Your decision to not take part will not result in any penalty or loss of benefits and will not affect the medical care or benefits to which you are otherwise entitled.
If you decide you do not want to participate in this research study, you may still participate in other studies. Your alternative to participating in this study is not to participate.
What if I participate now and change my mind later or I am removed from the study? You may withdraw from the study at any time for any reason. Your decision to withdraw will not result in any penalty or loss of benefits and will not affect the medical care or benefits to which you are otherwise entitled.
In order to withdraw, please send an email to the principal investigator at the Healthy Nevada Project email: renownIHI @ renown. org.. If you withdraw from the study, you will no longer receive any emails or other communication as part of the study. Any information that has already been added to your medical record will remain in your medical record. However, no new information from the study will go into your medical record.
Additionally, you may ask us to delete your information and destroy any stored samples. Any information and samples that Renown Health has stored that are linked to you will be deleted, although it may take some time for this request to be processed and fulfilled because certain laws may require Renown Health and Helix to retain the information for a certain amount of time. If this is the case, we will let you know. This will not impact or delay your withdrawal from
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