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.
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.
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.
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.
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 if they choose, 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.
A: You will have no-cost genetic testing performed for some of the most common hereditary conditions often missed during routine care. Helix will sequence your DNA, store the resulting genetic information, and give you access to their website to view your genetic results. When sequencing and genetic interpretation has been completed, you will receive the Helix Health product where you can learn whether you have any inherited genetic variants that may increase your risk for the following conditions: Familial Hypercholesterolemia, Hereditary Breast and Ovarian Cancer Syndrome, and Lynch Syndrome. If you are found to be at increased risk for any of these conditions, you will be offered genetic counseling at no cost so that you may learn more about your genetic results and the impacts on your health.
You will also receive access to the My Healthy Nevada Traits products on your Helix account at no-cost. Through this product, you will be able to learn and explore your genetic insights related to your 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.
In addition, you and future generations may benefit indirectly from participating because of the overall results of this project. Those results may shed light on the health of our entire community, and they may help us make better health decisions in the future.
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 NASH Liver Disease Study, to participants interested in taking part.
A: Nevada residents over the age of 18 years with a valid, personal email address and a password (an email which is not shared with anyone and is not a work email address). Renown patients who reside just outside of Nevada but seek care at Renown Health are also eligible to participate.
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.
A: Yes, of course! Visit our website at healthynv.org to learn how to join.
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.
A: On average, the testing appointment takes about 20 minutes. Please keep in mind that you can’t eat, drink (even water), chew gum or use tobacco products for 30 minutes prior to spitting.
For participants, the appointment typically consists of a few minutes of consultation, signing the consent form and collecting a saliva sample.
A: You will be asked to provide a saliva sample. In other words, you will be asked to spit into a tube until you produce a certain amount of saliva. Once collected, your sample will be packaged and shipped to Helix where your DNA will be extracted and sequenced.
A: We ask that you don’t 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!
In addition, each participant will need to have their own personal and valid email address (an email which is not shared with anyone and is not a work email address) as well as their email password.
A: We have several options for you:
A: If you join onsite with one of our Genomic Representatives, 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.
If you join from home then you will receive instructions when you receive your at home test kit on how to create your Helix account and register your DNA test kit to your account.
A: Your saliva sample will be sent to Helix’s lab for processing. Helix will sequence and store your genetic information from your sample and return genetic results directly to you on your online Helix account. 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. If you are a Renown patient, your clinical results may also be added to your medical record when testing is complete and viewable through MyChart.
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. For example, you will receive an invitation to fill out our Health Determinant Survey. Upon filling out the survey you will be entered to win a prize valued at approximately $250.
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 may also be populated to a patient’s Renown medical record when testing is complete and viewable on MyChart.
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
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.
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 may also be populated to your medical record and viewable through MyChart if you are a Renown patient and joined onsite with a member of the research team.
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.
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.
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.
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.
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.
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).
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.
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.
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.
A: There have been NO known cases of law enforcement contacting a private company like Ancestry, 23andMe or Helix. This would be unprecedented.
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.
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.