- About the Healthy Nevada Project
- Benefits to the Participants
- Who can join the study?
- What You Need to Know Before You Test
About the Healthy Nevada Project
Q: What is the goal of the project?
A: The Healthy Nevada Project is a population health study. 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 make better decisions about your health.
Q: Does it cost to participate?
A: No, you can enter the study at no cost. If we find any genetic variants with increased health risk in your DNA, you will be provided genetic counseling at no cost and you will be referred to your primary care provider. Any follow-up care or treatment by your primary care provider will be charged to your health insurance and you, in the same way any other healthcare is charged.
Q: When did this project start?/How long has this project been running?
A: The first phase of the Healthy Nevada Project (HNP) was launched in September 2016 with ten thousand Nevadans joining the study. In March 2018 the second phase of the project was introduced, inviting forty thousand more Nevadans to participate. In May 2019 the third phase of the HNP began in Las Vegas and southern Nevada.
Q: Who is involved?
A: Renown’s Institute for Health Innovation (Renown IHI) is owned by Renown Health – a locally governed and locally 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, a personal genomics company, Helix, and a telegenomics technology and services company, Genome Medical, have joined the project. Helix handles the 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. In order 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.
Benefits to the Participants
Q: How do I benefit from this study?
A: Your DNA will be tested at no-cost. Helix will then sequence your DNA, store the resulting genetic information, and give you access to their website with other DNA-based products. When sequencing has been completed, you will receive the My Healthy Nevada Traits App at no-cost. Through this app, 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 app does not contain health results.
If you had consented to be notified, you would be informed about your inherited genetic variants that increase risks for the following conditions: Familial Hypercholesterolemia, Hereditary Breast and Ovarian Cancer Syndrome, and Lynch Syndrome. In addition, you 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.
Q: Will I be opting into future research studies by participating in this project?
A: No, but you will have the opportunity to opt-in to additional research. Research is an opt-in component of the study. We recommend participants opt-in because this is a way for you to be informed about further health conditions the project will be reporting on in the near future. Also it is a mean for us to gather data important to modeling health outcomes.
Renown IHI may open additional clinical trials in specific disease areas to participants interested in taking part. All participants who opt-in to research will receive questionnaires from Renown IHI to strengthen the data set we are collecting and help us determine the relationships between genetics, other health determinants, certain health conditions, and the environment.
Who Can Join the Study?
Q: Who can take this test?
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).
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!
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 and begin the consent process, you simply select that you have already been sequenced with Helix. We will consent you to the research trial and an ambassador will add the “HealthyNV Traits App” to your Helix account so that you can access your results.
What You Need to Know Before You Test
Q: How long does the testing appointment take?
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.
Q: How is the testing done?
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. Your DNA will be extracted from your saliva sample.
Q: How should I prepare for the test?
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.
Q: How do I sign up for the Healthy Nevada Project?
A: You can schedule an appointment online for our Reno and Las Vegas locations or visit one of our drop-in, no appointment necessary, locations or special events (limited dates and times apply).
Q: How do I create a Helix account?
A: Please click here to create a Helix account prior to your appointment, and have your personal e-mail login ID and password memorized or written down for your visit.
Q: I have created a Helix account and I am being asked to enter a kit ID. What do I do at this step?
A: You can stop here and close the page or logout. You will receive your kit when you come on site to test and we will help you through the process of linking the kit to your account.
After You Test
Q: I finished my test. What’s next?
A: After your DNA has been sequenced, the scientists at Renown’s Institute of Health Innovation will analyze your DNA and if there are any positive findings, you will be contacted by our partner Genome Medical to discuss your results. Participants with positive findings will be informed about inherited genetic variants that increase risks for the following conditions: Familial Hypercholesterolemia, Hereditary Breast and Ovarian Cancer Syndrome, and Lynch Syndrome.
If you don’t hear from Genome Medical, it means we didn’t find any genetic variant associated with the above conditions we are screening for at the moment.
When sequencing has been completed, you will receive the My Healthy Nevada Traits App at no cost. Through this app, 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 app does not contain health results.
If you consented to be contacted, you will also receive an invitation to fill out our Health Determinant Survey. Upon filling out the survey you will be entered to win a prize, such as an IPhone, gift card, or similar prize to be disclosed at the time of survey distribution.
Q: What if I want to learn more about my DNA?
A: Once your DNA has been sequenced, you may visit the Helix store for apps that might be interesting to you.
Note: All third-party transactions made through the Helix store are independent and not affiliated with the Healthy Nevada Project.
Q: Do I need to purchase more Apps from the Helix Store?
A: No. Participants are not required to purchase anything.
What to Expect from Your Results
Q: What kind of results will I receive?
A: You will receive results only if you consented to be notified and only if we find that you carry genetic variants that could affect your health. Participants with positive findings will be informed about inherited genetic variants that increase risks for the following conditions: Familial Hypercholesterolemia, Hereditary Breast and Ovarian Cancer Syndrome, and Lynch Syndrome.
Q: Why only these three conditions?
A: These three conditions are CDC’s (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 will enable you to have a better outcome.
The Healthy Nevada Project will continue to report on more hereditary risks in the near future. With the advancement of genomic medicine the researchers will update the screening of your DNA, meaning that we will add new markers and new inherited conditions and will notify you as we make new analyses available to consenting individuals.
Q: What are Clinically Actionable Conditions?
A: The HNP study only reports on 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 diseases, you and your primary care provider can follow an action plan that will enable you to have a better outcome.
Q: When will I find out about my results?
A: You will be notified by email when your sample reaches the Helix lab with instructions on how to access your exclusive My Healthy Nevada Traits App (sequencing normally takes 8-10 weeks). The sequencing results will then be analyzed by scientists of the Renown Institute for Health Innovation. If you consent to receive clinical results and are shown to be at risk, a Genome Medical representative will contact you to notify you about your results and to offer guidance. Keep in mind, reviewing this large amount of data takes a long time but we will ensure everyone at risk is contacted. The whole process from sample collection to receiving your results may take 4-6 months.
Q: How do I interpret my results?
A: You don’t need to figure out your results alone. There will be a whole team of experts to design the best action plan for you and your family. If you choose to be notified of your genetic health risk, you will receive a phone call from a Genome Medical coordinator to schedule a consultation with a genetic counselor. The genetic counselor will explain your personal report and refer you to your primary care provider with all the necessary information. Your primary care provider will run more tests to verify the results and then suggest next steps in care, lifestyle changes, screening and prevention that you can take to reduce your and your family member’s risk.
Q: What if I don’t have a genetic variant?
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 and will not hear from us. No news is good news!
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 59 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 the 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 59 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 the 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.
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 important 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 place in a public database?
A: No, it will not. The Healthy Nevada Project is a research study and not a publicly available database that law enforcement can use.
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 genetic information collected as part of the Healthy Nevada Project (HNP) is not part of the HNP participant’s Renown Health designated medical record set. 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 was 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.
Q: What is in your informed consent?
A: Our informed consent is a form that will tell you all of the information about your involvement in this study. Please click on the link to the right to download and review a copy of the consent document. We will ask you to sign a copy of this on site, so no need to bring a copy with you.