GenoWell

GenoWell is a community health research program, supported by Rochester Regional 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.

GenoWell aims to enroll 100,000 participants who live in New York and are over 18 years of age in this community health research program. Currently, participants need to be a Rochester Regional Health primary care patient to participate.

No. Because this is a research program, 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 a 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.

No. Research studies include only people who choose to participate, so GenoWell 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 or employment at Rochester Regional Health. 

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 GenoWell research consent form, which provides confirmation of your informed consent.

The Consent Process:

1. Create a MyCare account if you don’t already have one. You can find instructions here.

2. Click on the “Enroll 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 MyCare account.

If you received an invite to join GenoWell in your MyCare account, you may also click the link in that message to take you to the enrollment website.

3. After you log into your MyCare account, 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 GenoWell 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 GenoWell study team by phone at (585) 922-4366 or email at GenoWell@rochesterregional.org.

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 also be available in your medical record. You will then receive a MyCare message with next steps for providing your DNA sample at a participating Rochester Regional Health lab. 

Please note: The information provided before informed consent is signed may be stored by Rochester Regional 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 that the U.S. 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 increases your risk of early coronary artery disease and heart attacks.

· Hereditary breast and ovarian cancer (HBOC): A hereditary form of breast and ovarian cancer, specifically linked with abnormalities in two 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.

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. 
 

GenoWell 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. GenoWell 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.
3. Participants are encouraged to reach out to a GenoWell team member to have their questions answered so they can be informed about the research in all of the ways necessary. GenoWell values diversity and inclusion in this program, so that all community members can not only have access to proactive healthcare 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 GenoWell 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. GenoWell 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 Rochester Regional Health 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, the Genetic Information Nondiscrimination Act of 2008 (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.

It is important to note that 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 Rochester Regional 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 Rochester Regional 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 New York 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 GenoWell 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 New York 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 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. 

For questions related to GenoWell, please contact the research study team at GenoWell@rochesterregional.org or at (585) 922-4366.

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