ImagineYou

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 you can use to review and sign the research consent form which provides confirmation of your informed consent.

The consent process:

1. Create an account with My Sanford Chart if you don’t already have one. You can find instructions at mysanfordchart.org/mychart.
2. Visit 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.
   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 call a member of the ImagineYou study team 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 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 message in My Sanford Chart with 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.

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 the Centers for Disease Control and Prevention 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 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 and are also at an increased risk of developing endometrial, ovarian, upper GI, brain, pancreatic and/or other cancers.

Additionally, 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 healthcare provider will receive health results from the genetic screening that will indicate if you have inherited certain risk factors in your DNA. About 1% to 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 give you the chance to schedule a genetic counseling appointment at no cost to you or your insurance.

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

Most participants will receive results within two to four weeks of providing their DNA sample, though it could take up to six weeks. 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.

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 uniqueness 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 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 tests and general screenings 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. They can also discuss medical recommendations and how you can approach sharing important information with others. Those communications with a genetic counselor would be separate from ImagineYou.

ImagineYou
(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.

Helix
(844) 430-0468
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 contact 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 affect 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:

• Your information (your genetic information and health records) is 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, 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 FAQs 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 or managers), 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. You should read your policy carefully to understand how results could affect 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 Standards 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.