ImagineYou

ImagineYou is a community health research program supported by Sanford Health 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 healthcare and support new research discoveries.

ImagineYou aims to enroll 100,000 Sanford Health participants or individuals who are over 18 in this community health research program.

No. Participation has no-cost and the genetic testing provided will not be billed to your health insurance or to you.

No. Research studies include only people who choose to participate, so ImagineYou 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 care at Sanford Health.

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 a link to review and sign the research consent form which provides confirmation of your informed consent.

  The consent process:

1. Create a My Sanford Chart account if you don’t already have one. You can find instructions at mysanfordchart.org/mychart.
2. Click on the “Get Started ” button on this website. This will bring you to the enrollment website from our genomics partner, Helix. You will be asked to confirm your identity on the next step by logging into your My Sanford Chart account.
   a. If you received an invite to join ImagineYou Genetic Screening Program in your My Sanford Chart account, you may also click the link in that message to take you to the enrollment website.
3. After the login to your My Sanford Chart account is complete, some of your contact and personal information will be shared with Helix to assist with the enrollment process. You will then visit Helix’s enrollment website where you can learn more information about ImagineYou and proceed to start the enrollment process by answering questions to see if you are eligible. Please note, only one email address may be used per participant. If you currently share an email account with another participant, a unique email address will be needed to proceed. To change your email address associated with your My Sanford Chart account, please update your personal information under Account Settings.
4. Once your eligibility is confirmed, the research consent form will be available to you for review. 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 ImagineYou study team by phone at (888) 424-2332 or email at imageneticsinfo@sanfordhealth.org, however, email is generally not a secure way to communicate, as there are ways for unauthorized users to access the communication. Email should not be used to convey information of an urgent nature. Please consider limiting the personal information you provide in an email to protect your confidentiality.
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 from research.docusign via DocuSign and it will be available in your medical record You will then receive a My Sanford Chart message with next steps for providing your DNA sample at a Sanford Laboratories location.

Please note: The information provided before informed consent is signed may be stored by Sanford Health 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.

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 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): A hereditary form of very high cholesterol that causes heart disease at an earlier age than the general population
• Hereditary breast and ovarian cancer (HBOC): A hereditary form of breast and ovarian cancer, specifically linked with abnormalities in the 2 most common genes (BRCA1 and BRCA2). Other cancers associated with these genes include prostate, pancreas, 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 and are also at an increased risk of developing endometrial, ovarian, upper GI, brain, pancreatic and/or other cancers.

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.

Together, you and your health care provider will receive health results from the genetic screening that will indicate if you have inherited certain risk factors in your DNA. About 1-2% (1 to 2 people out of 100) will be found to have a risk for one of the inherited cancer or heart conditions that are part of this study. If your results show you are at an increased risk for certain conditions, a member of the ImagineYou study 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 blood sample to the time you receive your health test results. Typically, your Ancestry and Traits results are ready within 8 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 ImagineYou focuses on three specific conditions:

• Hereditary breast and ovarian cancer syndrome
• Lynch syndrome (increased risks for colorectal and endometrial cancer)
• 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 testing.

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 testing 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 testing. There are a few reasons for this. First, Helix testing 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 testing.

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 ImagineYou 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 healthcare provider about the results of this test and whether additional or different genetic testing 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 testing or screening recommendations are indicated. 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 ImagineYou.

Our partner, Helix, performs Exome+ sequencing on participant samples. This testing 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 Sanford Health and other partnering healthcare 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 healthcare provider and with the consent and payment of the patient.

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, you can contact a member of the ImagineYou study team by phone at (888) 424-2332 or by email at imageneticsinfo@sanfordhealth.org, however, email is generally not a secure way to communicate, as there are ways for unauthorized users to access the communication. Email should not be used to convey information of an urgent nature. Please consider limiting the personal information you provide in an email to protect your confidentiality.

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.

ImagineYou Genetic Screening Program
(888) 424-2332
imageneticsinfo@sanfordhealth.org

Note: email is generally not a secure way to communicate, as there are ways for unauthorized users to access the communication. Email should not be used to convey information of an urgent nature. Please consider limiting the personal information you provide in an email to protect your confidentiality.

For questions related to the informed consent process and using the informed consent website, 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:

Phone: (844) 430-0468

Email: support@helix.com

If contacting Helix by email, note that email is generally not a secure way to communicate, as there are ways for unauthorized users to access the communication. Email should not be used to convey information of an urgent nature. Please consider limiting the personal information you provide in an email to protect your confidentiality.

Online form

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 ImagineYou 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 Sanford Health, and by other members of the Helix Research Network. That means, by agreeing to participate in the study, you are agreeing to have your information included in future research projects that are approved by Sanford Health 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 Sanford 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 information (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 Sanford Health 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 Sanford Health 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 state 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.

If you decide to participate in the ImagineYou 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 state 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.