FAQ
FREQUENTLY ASKED QUESTIONS
About the Healthy Nevada Project
Q. What is the Healthy Nevada project?
A: The Healthy Nevada Project is one of the largest community-based population health programs in the world. Our goal is to understand factors that determine health outcomes—one of these factors is your genetics. We hope to learn how your genetics impact your personal health trajectory and use this information to help you and your healthcare providers make more informed decisions about your health.
Q. Does it cost anything to participate
A: No, you can enter the study at no cost. Participants receive clinical grade genetic sequencing and screening for three of the most common hereditary risks, as well as regional ancestry and wellness insights at no cost. If we find any genetic variants indicating an increased health risk in your DNA, you will be contacted directly regarding your results and be offered no-cost genetic counseling with a licensed genetic counselor to discuss your individual results. Any follow-up care or treatment required after the disclosure of your results, such as through your primary care provider, will be charged to you and/or your health insurance in the usual manner.
Q. When did this project start/how long has it been running?
A: The first phase of the Healthy Nevada Project (HNP) was launched in September 2016 with 10,000 Nevadans joining the study in partnership with 23andMe. In March 2018, the second phase of the project was introduced with our partners at Helix for a more clinically focused experience, inviting 40,000 more Nevadans to participate. In May 2019, the third phase of the HNP began to include Las Vegas and southern Nevada. The Healthy Nevada Project will continue indefinitely with an expectation of enrolling over 250,000 participants into the study.
Q. Who is involved
A: The Healthy Nevada Project is powered by Renown Health. Renown’s Institute for Health Innovation (Renown IHI) is a partnership between Renown Health and the Desert Research Institute. Renown Health is a locally governed and owned, not-for-profit integrated healthcare network serving Nevada, Lake Tahoe, and northeast California. Desert Research Institute is a recognized world leader in investigating the effects of natural and human-induced environmental change and advancing technologies aimed at assessing a changing planet.
During phase two, the personal genomics company, Helix, and a telegenomics technology and services company, Genome Medical, joined the project. Helix handles DNA sequencing and secure data storage while Genome Medical provides medically licensed genetic counseling to participants with positive findings.
Q. Why Helix?
A: We learned from the pilot study that we needed to integrate the Healthy Nevada Project into clinical care. To do this, we needed a vendor that could provide clinically actionable results to enrolled patients and their physicians. Renown IHI research teams will have greater depth and quality of DNA data thanks to Helix’s Next Generation Sequencing (NGS) technology and one of the world’s largest CAP- and CLIA accredited exome sequencing labs.
Benefits to the Participants
Q. How do I benefit from the study
A: Our study offers screening and clinical results for 3 inherited genetic conditions: Hereditary Breast and Ovarian Cancer Syndrome, Lynch Syndrome, and Familial Hypercholesterolemia. There is no cost to you as a participant and the results from the genetic testing will be returned directly to you and may also be made a part of your medical record. These results may indicate you are at increased risk for certain conditions, such as heart disease
or certain cancers, that when detected early can have a positive impact on your health. You may also receive insights into your personal ancestry and other non-medical traits such as your tolerance to lactose or gluten that may be of interest to you.
Q. Will I be opting into being contacted about future research studies by participating in this project?
A: Yes, but you will be under no obligation to participate in future research studies and may opt-out of being contacted regarding additional research studies at any time by contacting the study team directly. Study participants are often the first to be offered new research opportunities that may benefit them.
For example, Renown IHI may open additional clinical trials in specific disease areas, such as our M/NASH Liver Disease Study, to participants interested in taking part.
Who Can Join the Study?
Q. Who can join the study?
A: Nevada residents over the age of 18 years with an active MyChart account. Renown patients who reside just outside of Nevada but seek care at Renown Health are also eligible to participate.
Need a MyChart visit https://mychart.renown.org/mychart/signup
Q. Are children under the age of 18 allowed to enroll in the study?
A: Currently the Healthy Nevada Project is not enrolling children under the age of 18. Please check back in the future for updates on how children can participate.
Q: If I participated when the project used 23andMe test, can I participate again and take the Helix DNA test?
A: Yes, of course! Visit our website at healthynv.org to learn how to join.
Q: Can I participate in the Healthy Nevada Project if my DNA has been previously sequenced by Helix?
A: Yes! When you come on site for your appointment, notify the Genomic Representative you are working with that you have already been sequenced with Helix. We will make sure you are consented appropriately and will add the results products for the study to your Helix account so that you can access your results.
What You Need to Know Before You Test
Q: How long does the appointments take?
A: On average, the virtual and testing appointments takes about 20 minutes each. At your virtual appointment a Genomic Representative will answer any questions, have you sign the consent form and schedule you for your appointment to provide a sample.
If you are providing a blood sample, fasting is not required, however if you are scheduling your blood sample with other labs please follow whatever guidelines they provide for those tests.
If you are providing a blood sample at the same time for the Enhanced Liver Fibrosis (ELF) test please remember to discontinue from taking anything with B7, normally found in multivitamins/biotin, 3 days prior to your blood draw.
If you are providing a saliva sample you cannot eat, drink (even water), chew gum or use tobacco products for 30 minutes prior.
Q: How is the testing done?
A: If you are providing a blood sample, the draw is just like a normal lab draw.
If you are providing a saliva sample we will provide you a collection tube at your appointment that you will spit into.
Once collected, your sample will be packaged and shipped to Helix where your DNA will be extracted and sequenced.
Q: How should I prepare for the appointments?
A: Prior to your virtual appointment we recommend participants review the consent form prior.
Blood sample: no fasting required unless you are having this done with other labs and these require you to do so. Please follow guidelines provided with those labs.
If you are providing a blood sample at the same time for the Enhanced Liver Fibrosis (ELF) test please remember to discontinue from taking anything with B7, normally found in multivitamins/biotin, 3 days prior to your blood draw.
Saliva sample: We ask that you not eat or drink anything for at least 30 minutes prior to testing. This includes water, chewing gum, smoking, using tobacco products or even taking a cough drop!
Q: How do I sign up for the Healthy Nevada Project?
A: We have several options for you:
- Schedule an appointment through MyChart,
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- Select Visits (always visible from main screen)
- Select Schedule an Appointment
- Select Genetic Research Virtual Visit
- Select the date and time that works best for you
- Need a MyChart? Go to mychart.renown.org to sign up.
- You can also call us at 775 982 6914.
Q: How do I create a Helix account?
A: You will receive an email from Helix within days of testing to access your account. Participants can use their MyChart login for ease of access.
After You Test
Q: I finished my test. What’s next?
A: Your sample will be sent to Helix’s lab for processing. You will receive an emai from Helix within days of testing to access your account. Participants can use their MyChart login for ease of access. Helix will sequence and store your genetic information from your sample and return genetic results on your Helix account, populated to your medical record and viewable through MyChart. You will be provided with two results products on your Helix account under the results tab. Participants typically receive ancestry and wellness insights through the “My Healthy Nevada Traits” product first and then clinical results for Familial Hypercholesterolemia, Hereditary Breast and Ovarian Cancer Syndrome, and Lynch Syndrome in the “Helix Health” product shortly thereafter. Results can take up to 12 weeks to be returned and Helix will notify you by email when your results are available to review on your Helix account.
Although rare, if a genetic mutation is discovered for any of the conditions tested, you will be contacted by phone to discuss your results and be provided with additional resources about your findings, such as no cost genetic counseling with a licensed genetic counselor. You will not be contacted if there are no actionable findings.
Throughout the duration of the study, you may be periodically contacted by email to complete voluntary surveys to help improve our research. Some surveys may include additional incentives for completion that will be disclosed at the time of distribution.
Q: What kind of results will I receive?
A:. You will receive two kinds of results if you decide to participate. Participants receive non-clinical genetic results through the “My Healthy Nevada Traits” results product. Through this results product, you will be able to learn and explore your genetic insights related to your regional ancestry and how your DNA can influence your body’s response to the foods you eat. Please note: this results product does not contain health results.
Clinical genetic results for Familial Hypercholesterolemia, Hereditary Breast and Ovarian Cancer Syndrome, and Lynch Syndrome are provided through the “Helix Health” results product. Participants will be notified by email when their results are available to be viewed directly on their Helix account. Results will be accessible for as long as the Helix account is active, and participants can download a clinical report for the genetic conditions being tested. Results will also be populated to a patient’s Renown medical record when testing is complete and viewable on MyChart.
Q: What is Familial Hypercholesterolemia (FH), Breast and Ovarian Cancer and Lynch Syndrome?
Familial Hypercholesterolemia (FH): Increased risk for early heart disease and high cholesterol
Breast & Ovarian Cancer Syndrome (BRCA 1&2 genes): Increased risk for Breast, Ovarian, Prostate, and Pancreatic cancers
Lynch Syndrome: Increased risk for colon and endometrial cancers
Q: Why only these three conditions?
A: These three conditions are CDC (Centers for Disease Control) Tier 1 clinically actionable conditions. This means that actions can be taken to treat, prevent, delay or reduce symptoms of these health conditions. Therefore, if you learn that you or your family member have an increased risk of developing any of these conditions, you and your primary care provider can follow an action plan that may help improve health outcomes.
The Healthy Nevada Project may expand to report on additional hereditary risks in the future. Your stored genetic information may be used for future screening of other genetic conditions as deemed appropriate by the research team. If you are found to have any actionable findings for other genetic conditions tested for in the future, you will be contacted directly to discuss your results. Any such results would be considered “incidental findings” as they are not included in the original scope of the study.
Q: When will I find out about my results?
A: Sequencing and return of results may take up to 12 weeks once your sample has been received at the Helix lab. Helix will notify you by email with updates regarding the status of your sample and when your results are ready to be viewed on your Helix account. Your genetic results will also be populated to your medical record and viewable through MyChart if you are a Renown patient.
Q: How do I interpret my results?
A: You do not need to figure out your results alone. Although rare, if a genetic variant is discovered, you will be contacted by phone to discuss your results and be provided with additional resources about your findings. All participants found to have a clinical finding for any of the conditions tested are offered no cost genetic counseling with a licensed genetic counselor or geneticist. These specialists can help you navigate your results and recommend the appropriate follow up care. It is important to also follow up with your primary care provider or other healthcare professionals regarding your results. Your primary care provider may run more tests to verify the results and then suggest the next steps in care, lifestyle changes, screening, and prevention that you can take to reduce your and your family member’s risk.
If no DNA variants are found for the conditions being tested, then you are not at increased risk and no action is needed. You may still be contacted by your provider for additional follow-up. If you are concerned about other genetic risks, it is recommended you speak to your healthcare providers to explore other options for expanded testing.
Q: What if I do not have a genetic variant for these conditions?
A: Only about 1% of the population will have the genetic variants we are currently screening for. That means about 99% of the study participants will not have a pathogenic/likely pathogenic variant for the 3 conditions we are currently screening for. If no DNA variants are found for the conditions being tested, then you are not at increased risk for the conditions tested and no action is needed. You may still be contacted by your provider for additional follow-up.
Q: Are these results final? Do I no longer need to worry about the conditions you are screening for?
A: Not completely – genetics is only a small portion of your risks for developing disease and we encourage all participants in the HNP to remain vigilant and regularly see a primary care doctor! Science is constantly evolving, and we know researchers have not identified all possible genetic variants that could be associated with these conditions. There are other genes known to increase the risk for cancer or cardiovascular disease development that we are not testing for yet.
Therefore, if you have a personal or family history of cancer, cardiovascular disease, or a cardiovascular event, be sure to share this information with your medical provider. Your doctor can help you determine if further genetic testing is appropriate.
The American College of Medical Genetics provides a list of other genetic conditions that can be diagnosed and managed through genetic screening, Healthy Nevada Project is currently reporting on the top 3 conditions: Hereditary Breast and Ovarian Cancer Syndrome, Lynch Syndrome, and Familial Hypercholesterolemia. The Healthy Nevada Project will continue to report on more hereditary risks in the near future. With the advancement of genomic medicine, researchers will update the screening of your DNA.
Q: Will I get any more results in the future?
A: The American College of Medical Genetics provides a list of other genetic conditions that can be diagnosed and managed through genetic screening. Healthy Nevada Project is currently reporting on the top 3 conditions: Hereditary Breast and Ovarian Cancer Syndrome, Lynch Syndrome, and Familial Hypercholesterolemia. We will continue to test for and report on other hereditary risks in the near future. With the advancement of genomic medicine, researchers will update the screening of your DNA. Continue to check your emails regularly and if you have any concerns about your health, consult with your physician.
Privacy Protection
Q: What is your privacy policy? How is my data used?
A: Unless explicitly stated differently in the Informed Consent for the Healthy Nevada Project, we follow the privacy policies of Renown Health. Any data obtained from your participation in this study is used for research purposes as outlined in our Informed Consent Form.
Q: What steps have you taken to ensure my information is kept private?
A: To help us protect your privacy, we have obtained a Certificate of Confidentiality (CoC) from the National Institutes of Health. The researchers can use this Certificate to legally refuse to disclose information that may identify you in any federal, state, or local civil, criminal, administrative, legislative, or other proceedings, for example, if there is a court subpoena. The researchers will use the Certificate to resist any demands for information that would identify you.
It is also important to note that all information is de-identified for research purposes. Your accounts with Helix and the products you may receive or purchase in the Helix Store are not accessible to any researcher at Renown or DRI. Helix will only share the parts of your genome that are relevant to this study with the Healthy Nevada Project. If researchers make findings that are deemed important to communicate back to individuals and you consented for us to do so, the Principal Investigator will be able to re-identify you for the purposes of communicating this vital information back through trained medical staff. Examples of this information are increased risk of developing serious diseases such as cardiovascular disease or cancer.
Federal and state laws are in place to protect your protected health information (PHI).
Q: Will my DNA be placed in a public database?
A: No, it will not. The Healthy Nevada Project is a research study and not a publicly available database. Any data shared with approved research partners is kept de-identified to maintain your privacy.
Q: Will my insurance company use my genetic results against me (i.e. will they deny future claims because of my results?)
A: The Genetic Information Nondiscrimination Act of 2008 (GINA) is a federal law that protects individuals from genetic discrimination in health insurance and employment. With GINA’s protections, you can feel comfortable talking about family health history with your family and healthcare providers.
GINA legally forbids health insurers to request, require, or use genetic information to make decisions about your eligibility for health insurance and your health insurance premium, contribution amounts, or coverage terms. This means that it is against the law for your health insurer to use a genetic test result, or family health history, as a reason to deny you health insurance or decide how much you pay for your health insurance. However, GINA does not cover life insurance, disability insurance, or long-term care insurance.
To learn more about how you are and are not protected, check out ginahelp.org.
Q: Can the police ask Renown Health for my DNA sequence?
A: The stored genetic information collected as part of the Healthy Nevada Project (HNP) is maintained as de-identified data and only interpreted genetic results are included in a participant’s Renown Health designated medical record. Even if law enforcement were to subpoena a HNP participant’s medical record from Renown Health, they would not receive any individually identifiable genetic information. If an attempt were made to obtain individually identifiable genetic information directly from the HNP, HNP would legally oppose such attempts as well as give the individual HNP participant legal notice and an opportunity to object to such efforts.
Q: Has law enforcement ever contacted a private genetic sequencing company before to obtain personal information?
A: There have been NO known cases of law enforcement contacting a private company like Ancestry, 23andMe or Helix. This would be unprecedented.
Q: Could there be an extreme situation where law enforcement might request access to my information?
A: There are very specific edge cases that might be adjudicated in a court where law enforcement could perhaps attempt to break our Certificate of Confidentiality: subpoenas related to child endangerment, capital murder, etc., as yet this has never occurred.
Informed Consent
Q: What is in your informed consent?
A: Our Informed Consent Form is a form that will tell you all of the information about your involvement in this study. You can review the consent form on healthynv.org. We will ask you to sign a copy prior to or during your appointment.