PreciselyYou

PreciselyYou is a community health research program, supported by WakeMed to help improve the health of the participants and the community we serve. Through no-cost genetic screening, the program looks at how your DNA could impact your health. The information we gain may help us improve personalized health care and support new research discoveries.

WakeMed PreciselyYou aims to enroll 100,000 participants who are over 18 years of age in this community health research program.

No. There is no cost to participate and the genetic screening provided will not be billed to your health insurance or to you. If your blood sample collection occurs during a clinic visit, your participation will not affect normal charges for that visit.

If you test positive for one of the conditions being screened, you will be offered one genetic counseling appointment at no cost. However, any follow-up beyond the initial genetic counseling appointment will be considered clinical care and you and/or your insurance company will be responsible for payment, as would be the case for any other clinical care you receive.

No. Research studies include only people who choose to participate, so Precisely You is completely voluntary. It is your choice whether or not you want to take part in this study and your decision will not impact your relationship with or employment at WakeMed.

We want to make sure you understand what is involved in the study so you can make an informed decision about your participation in the research. Signing up is easy and something you can do from home. If you decide to participate, we will ask you to answer a few questions to confirm you are eligible to participate. You will then be provided with a link to review and sign the PreciselyYou research consent form, which provides confirmation of your informed consent.

The consent process: 

1. Create a MyChart account if you don’t already have one. You can find instructions at https://mychart.wakemed.org. 

2. Click on the “Join Now” button on this website. This will bring you to the enrollment website from our partner, Helix. You will be asked to confirm your identity on the next step by logging into your MyChart account. 

• If you received an invite to join Precisely You in your MyChart account, you may also click the link in that message to take you to the enrollment website.

3. After you log into your MyChart account, some of your contact and personal information will be shared with Helix to assist with the enrollment process. This includes your name, email, phone number, date of birth and medical record number. Sharing this information is necessary to allow Helix to enroll you in the program and ensure a smooth process. You will then visit Helix’s enrollment website where you can learn more information about Precisely You and start the enrollment process by answering questions to see if you are eligible.

4. Once your eligibility is confirmed, the next step is to review the research consent form. It is important to read over the consent form carefully. If you have any questions about the study or the form, you can contact a member of the PreciselyYou study team by phone at preciselyyou@wakemed.org  or call 919-350-9696. 

5. Once you are ready and all of your questions have been answered, sign the consent form. You will be sent a copy of your signed consent for your records via email and it will be available in your medical record. 

Please note: The information provided before informed consent is signed may be stored by WakeMed and/or Helix to keep track of potential participants and may be used to contact those who are interested. Only those who are eligible may sign an informed consent form to participate.

You may provide your blood sample at any of WakeMed’s convenient outpatient laboratory locations. No appointment is needed, and walk-ins are welcome. You can see a full list of locations and operating hours on our website: Find a Location. Please bring your photo ID, but insurance cards are not necessary.

Once your sample is received at Helix, they will complete DNA analysis, also known as sequencing. Sequencing reads the code contained within the DNA so that it can be used for research. You will also receive an email from Helix offering you the opportunity to create an optional Helix account.

Yes. You and your WakeMed care team will receive health results that will indicate if you have inherited certain risk factors in your DNA, meaning that the risk may have been passed from generation to generation in your family. Your family history alone, and standard medical screening tests, do not always identify risks for these conditions. Specifically, the test will tell you about your genetic risk for the following three conditions that the US Centers for Disease Control and Prevention (CDC) and other medical professionals consider to be important enough to warrant further investigation of treatment: 

• Familial hypercholesterolemia (FH): An inherited form of very high cholesterol that causes heart disease at an earlier age than the general population
• Hereditary breast and ovarian cancer (HBOC): An inherited form of breast and ovarian cancer, specifically linked with abnormalities in the two most common genes (BRCA1 and BRCA2). Other cancers associated with these genes include prostate, pancreatic and melanoma type cancers.
• Lynch syndrome: The most common cause of hereditary colorectal (colon) cancer. People with Lynch syndrome are more likely to get colorectal cancer at a younger age. 

In addition, if you sign up for a Helix account, you’ll receive information about your genetic regional ancestry and how your DNA may influence certain traits, such as your caffeine sensitivity and sleep patterns.

You and your WakeMed health care provider(s) will receive health results from the genetic screening that will indicate if you have inherited certain risk factors in your DNA. Approximately 1-2% (one to two people out of 100) will be found to have a risk for one of the inherited cancers or the heart condition included in this study. If your results show you are at an increased risk for certain conditions, a member of the WakeMed PreciselyYou team will contact you about your results and you will be able to schedule a genetic counseling appointment at no cost to you or your insurance. 

Your health care provider may refer you to a specialist for more information, genetic counseling and/ or additional screenings, if needed.

The process takes about 12 weeks from Helix receiving your sample to the time you receive your health test results. Typically, your Helix ancestry and traits results are ready within eight weeks of the Helix lab receiving your sample. These results are available to you if you have created an optional Helix account. It may take another month before your health results are ready to view, as extra steps are taken to ensure your health results are accurate.

The genetic screening test done for the PreciselyYou study focuses on three specific conditions: 

• Hereditary breast and ovarian cancer syndrome 
• Lynch syndrome (increased risks for colorectal and other cancers) 
• Familial hypercholesterolemia (very high cholesterol) 

We focus on these three conditions because they occur often enough in the general population. Plus, if you discover you have one of these conditions, there are specific actions you can take to reduce your risk. 

This genetic screening test does not analyze all the potential risks linked to your DNA. It is not meant to replace in-depth genetic screening. 

Talk to your doctor if you are concerned about your risks or have a previous diagnosis of any of the tested conditions.

No. The results of your ancestry and traits may be different from what you understand to be true about yourself. This does not mean the information provided to you about these results or your health results is inaccurate.

It is important to understand that trait and ancestry results are estimates based on DNA patterns rather than definitive information. These results give insights into a person's genetic origins or predispositions. They do not guarantee the occurrence of specific ancestry or traits. While some traits are easy to predict based on genetic information, other traits are more complex and therefore more challenging to predict based on genetic data alone. Trait and ancestry results are different from Helix Health results. Helix Health screening looks for the presence or absence of specific genetic variants. Such variants have extensive evidence from the medical community linking them to risk for disease.

Genetic variations linked to ancestry and traits occur throughout the genome. They are responsible for the natural genetic diversity among people. These genetic variants estimate the most likely ancestry or traits that a person will have. They are not definitive and do not guarantee the occurrence of specific ancestry or traits.

Sometimes, the ancestry and traits we express do not match what is expected based on DNA screening. There are a few reasons for this. First, Helix screening may not include all of the genetic variants linked to a specific trait or ancestry. Also, there may be interactions between genes that are not yet fully understood. Genetic traits are often influenced by multiple genes making it difficult to predict precise outcomes. Finally, genetic traits can be influenced by the environment or other factors. These factors can interact with your genetic makeup and contribute to differences between the traits you express and the traits expected based on your DNA screening.

If you have a personal or family history of a condition covered by this test, it is important to know the results of this test do not change a previous diagnosis or any family history risk you might have. This is because there are other causes of cancer and heart disease that were not evaluated as part of this test. For example, lifestyle, family history, environment, personal medical history, and other genetic conditions all contribute to your overall health and personal risk for disease. In addition, the screening test provided as part of Precisely You does not evaluate all genes associated with cancer and heart disease. Also, this test may not identify all DNA variants in the genes that were tested.

You may want to speak with a genetic counselor or your health care provider about the results of this test and whether additional or different genetic screening and general screening may be appropriate for you. In particular, participants with a negative genetic test and a clinical diagnosis of one of the conditions screened for by this test are recommended to consider a diagnostic genetics consultation to identify whether additional genetic screening or screening recommendations may be beneficial. A genetic counselor is a medical professional specifically trained to help you understand how your genetic information may impact your health and the health of your family members, discuss medical recommendations, and discuss how you can approach sharing any important information with others. Those communications would be separate from PreciselyYou.

Our partner, Helix, performs Exome+ sequencing on participant samples. This screening reads the DNA sequence of most genes (plus many other regions of the DNA). An individual's DNA sequence is also called their genetic information. Through involvement in this study, participants will receive DNA test results for three medical conditions. These conditions include a genetic form of breast cancer, colon cancer and high cholesterol. There are no additional genetic test results planned for return through this research program at this time. This may change in the future if additional medical conditions become appropriate for general population screening. Participants will be notified of any updates before receiving new results.

Helix will store participants’ DNA sequence results for an unlimited time. Since participants’ genetic information has been sequenced and stored, it will be possible to use that information for future clinical genetic testing. Helix is actively working with WakeMed and other partnering health care institutions to offer opportunities for patients to learn more about their genetic information in the future. Such future clinical testing would only be performed at the request of an ordering health care provider and with the additional consent and payment by the patient.

A result of “test not performed” means the sample that was provided did not meet the quality standards needed to complete the DNA sequencing at the Helix lab. Some examples of why this might happen include, but are not limited to, issues with processing the sample and extracting the DNA, issues with the sample being read in the sequencing machine, or issues with the sequencing data not being a high enough quality for interpretation. Every sample and its associated data is checked at multiple stages for quality, and a typical sample is given a “Test Not Performed” result only after it has failed multiple attempts.

Most of these issues may be resolved by collecting another sample and therefore we encourage any participant who receives a TNP result to provide another sample. If this issue occurs again, additional review of the issue will be completed in order to provide the best next steps about additional sample collection.

If you have received a bone marrow or stem cell transplant as a treatment for blood cancer or another type of blood disease, it is recommended that you do not participate in this research study.

This study tests DNA from cells that are collected from your blood sample. These cells are often created by your bone marrow or by your stem cells. If you have received a bone marrow or stem cell transplant from a donor, your DNA and the DNA of your donor may be included in your specimen. Genetic test results may reflect the DNA of your donor, or they may be inconclusive.

If you have been a bone marrow or stem cell donor, this would not impact your genetic test results.

You may withdraw from the study at any time. 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.

To withdraw, please send an email to the PreciselyYou study team at preciselyyou@wakemed.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 research study will go into your medical record. Your withdrawal from the project will be appropriately noted in your medical record.

PreciselyYou is considerably different from these examples in the following ways: 

1. Each participant has to volunteer to participate. No data or samples are being used for research without a participant agreeing to participate. 

2. Each participant must review and complete a research consent form prior to their enrollment into the community health research program and prior to data and samples being used for any research purpose. 

   1. At the time of the Tuskegee study and for Henrietta Lacks, informed consent for research was not standard practice. Ethics boards that review research were not fully established, and researchers did not have to abide by the standards that we have today. Precisely You is reviewed by an ethics board called an Institutional Review Board or (IRB). They must abide by the federal rules that oversee human subjects research. The application that is submitted to the IRB must include all information about the research program as well as all documentation that describes the research program. 
   2. Because of this review process we now have many rules to abide by to run a research program ethically and in compliance with the rules of our institution and the federal government. This includes standards on how we inform participants if there are any changes to the research since they provided consent including new risks or new benefits. 
   3. In addition, we are transparent about all aspects of the research program. The consent form includes detailed information about participation, the risk and benefits of the study, what information a participant will and will not receive and what happens if there are discoveries made off of the information provided in the research program. 
   4. Participants are informed from the beginning that they can withdraw from the research program at any time. Therefore, they are in control of when they start participation and when they stop participating. Participants are encouraged to reach out to a PreciselyYou team member to have their questions answered so they can be informed about the research in all of the ways necessary. 

   3. Participants are encouraged to reach out to a PreciselyYou member to have their questions answered so they can be informed about the research in all of the ways necessary.

   PreciselyYou values diversity and inclusion in this program, so that all community members can not only have access to proactive health care learnings for their individual health, but also so that the diverse research resulting from this program can be applicable to enhancing the standard of care for all.

No. The Genetic Information Nondiscrimination Act of 2008 (GINA) is a federal law that makes it illegal for health insurance companies, group health plans, and most employers to discriminate against you based on your genetic information. However, this law doesn’t protect you against genetic discrimination by companies when they consider selling you life insurance, disability insurance, or long-term care insurance. These companies must still abide by GINA when it comes to health insurance.

The information you contribute to Precisely You will be used by researchers to study a wide range of questions around how DNA can impact health. The databases created in this research program will be used for future research by our genomics partner Helix, by us, and by other members of the Helix Research Network. The Helix Research Network is a network of health systems that work with Helix to create and offer community health research programs to their patients and members of their community. Precisely You is a Helix Research Network study. That means that by agreeing to participate in the study, you are agreeing to have your information included in future research programs that are approved by us and by Helix.

Researchers outside of the Helix Research Network may also study your coded information and samples but will not have access to information that directly identifies you. These researchers may work for health systems, universities, government agencies, companies like drug companies and other foundations or groups interested in research. Any sharing of information outside of the network will be carefully reviewed and approved to make sure it is ethical, secure and protects your privacy.

We may share discoveries that are made by WakeMed researchers through our website and newsletters.

Your privacy is very important to us, and we take many steps to ensure it is protected, such as: 

• Your personally identifiable information and data (your genetic information and health records) will be stored in secure databases. 
• We limit and closely monitor who can access your data. 
• We limit who is allowed to see information that could identify you, like your name or contact information. 
• Researchers who have access to your data must be trained and certified to work with this type of research data. 
• You can choose to withdraw and stop sharing your information at any time.

With few exceptions, GINA prohibits employers from discriminating against their employees on the basis of genetic information in any aspect of employment, including hiring, firing, pay, job assignments, promotions, layoffs, training, fringe benefits, or any other term or condition of employment. The law similarly prohibits labor organizations from excluding, expelling, or otherwise discriminating against an individual based on genetic information.

Importantly, GINA’s employment protections do not extend to all employees or in all circumstances. Most notably, these protections do not apply to employees at companies with fewer than 15 employees or to active members of the U.S. military.

No. Your decision to participate in, decline, or withdraw from the research study is completely voluntary and not required by WakeMed because of your employment. In making your voluntary decision, we encourage you to carefully review the above-referenced FAQ’s which, along with the Informed Consent form, more fully explain the research study and summarize risks and benefits of participating in this study, along with other important information, including your rights under the Genetic Information Nondiscrimination Act (GINA). Your voluntary decision will not be included in your WakeMed employment record (or be accessible to your manager(s)), nor will any results of your participation in the study (should you choose to participate). Your voluntary decision will not affect your compensation, benefits, job performance evaluation or any other decision related to your employment. A voluntary decision not to participate in this study will not result in any penalty or loss of employment and will not affect the medical care or benefits you receive and to which you are otherwise entitled.

Currently, federal and North Carolina law protections against discrimination based on genetic information by health insurers do not extend to providers of life, disability, and long-term care insurance. That means companies offering these kinds of insurance may request access to genetic information in your medical record as part of the insurance application process (including information generated as part of your participation in this study) and may legally consider this information in deciding whether to extend your coverage or in determining the price they charge you.

If you already have an existing life insurance, disability insurance, or long-term care insurance policy, new information about your health (including genetic information) generally may not be used to deny you continuing coverage under those policies. However, the terms of individual policies vary significantly and you should read your policy carefully to understand how results could impact your coverage or insurance rates.

WakeMed offers Life Insurance through Lincoln Financial to employees. Lincoln Financial does not consider genetic testing or biomarker testing as “treatment” when evaluating the pre-existing condition provision. That being said, we could have situations where an employee pursued treatment due to the results of genetic/biomarker testing, which could then potentially fall under the policy’s definition of treatment. But the testing itself would not be considered as treatment of a pre-existing condition.

If you decide to participate in the PreciselyYou study, your information will be stored in databases that are maintained and monitored by a team of IT and security professionals who are committed to safeguarding the information stored in those systems. These systems include numerous technical, physical and administrative safeguards that meet, and in some cases exceed, industry best privacy and cybersecurity practices, including standards established by the National Institutes of Science and Technology (“NIST”), the Association of International Certified Professional Accountants (“AICPA”), and applicable North Carolina and federal laws, such as HIPAA. Some of the technical safeguards we’ve implemented include rigorous identification, authorization and access controls, audit and logging procedures, configuration management, system and communication protections and endpoint monitoring, data loss prevention systems, encryption of data at rest and in transit, and vendor risk management procedures. Although we generally do not share the details of how these controls and safeguards have been configured, we can share that our privacy and security programs are reviewed annually by third party auditors to ensure our safeguards are operating as expected and in a manner consistent with industry standards.

If you have any questions about the study or the form, you can contact a member of the PreciselyYou study team by phone at preciselyyou@wakemed.org  or call 919-350-9696. 

For questions related to the informed consent process and using the informed consent website (including updates to email and phone number), and for questions related to the shipment of a sample collection kit, or creating or accessing an optional Helix account - Please contact Helix customer support by phone, email or by filling out an online request: (844) 430-0468 // support@helix.com // Online form: https://support.helix.com/s/contactsupport