Informed Consent, Health Compass

 

 

Why Informed Consent is important

 

Navigenics asks you to provide your informed consent to ensure that, before choosing to purchase the Navigenics® Health Compass service, you understand the process and are aware of the benefits, limitations and potential risks. Please review the information described below before you give your consent.

By agreeing to this Informed Consent, you authorize Navigenics to:

• Analyze your DNA for specific genetic markers that are associated with the specific health conditions and medication responses assessed (see “Conditions and Medication Responses included in this service” below).
• Obtain additional genetic data from your DNA using one or more additional technologies that we may incorporate over time in order to provide you more information about your DNA.
• De-link Your Account Information from Your Genetic Data and Your Phenotype Information (see “Confidentiality” below for definitions), in order to conduct our own internal research.

No tests other than those described in this form will be performed on your saliva or DNA sample without your separate, explicit written consent.

You will also separately have the option to contribute your genetic information to science through our service, in which case you authorize Navigenics to share Your Genetic Data and Your Phenotype Information anonymously with not-for-profit research organizations once it has been de-linked from Your Account Information.

You may wish to obtain professional genetic counseling prior to providing your consent. If you have questions regarding this Informed Consent you can speak with a board-certified Navigenics Certified Genetic Counselor prior to purchasing the Navigenics Health Compass service, at no charge. Please call Member Service at (866) 522-1585.

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Description and purpose of the service

 

Your genes, along with your environment and lifestyle choices, play a role in how likely you are to develop certain health conditions over your lifetime. Your genes can also impact how you respond to certain medications. The Navigenics Health Compass service is intended to help you learn more about your genetic information and what it may mean for your health. While the service does not diagnose whether you have, or will develop, any specific condition, or determine what medications you should take at which dose, knowing about genetic risk factors can serve as a tool to help you and your physician tailor your health-care needs. 

Everyone has variations in their DNA, called SNPs (pronounced “snips”), and current genetic research is trying to learn how specific SNPs are linked to having a higher or lower chance of various common health conditions, such as cancer, type 2 diabetes or heart disease, and also how specific SNPs are linked to responding well or poorly to, or developing side effects from, certain medications such as specific blood thinners, cholesterol lowering drugs, and chemotherapies.

Using a saliva sample to collect a sample of your DNA, Navigenics analyzes certain SNPs in your DNA in order to provide you with a personalized genetic risk estimate for certain health conditions and medication responses. These are SNPs that have already been reported in reputable scientific and medical journals as being associated with a higher chance of having the health conditions or with responding well or poorly to, or developing side effects from, certain medications.

After you order the Navigenics Health Compass service you will be able to speak with a certified Navigenics Genetic Counselor by telephone to discuss what your results mean for you. Our genetic counseling services are available to you at no additional charge. A Navigenics Genetic Counselor may contact you to help answer any questions you may have, but you are not required to speak with a genetic counselor. However, we encourage you to utilize these services if you have any questions at any point.

The information and services provided by Navigenics do not establish a doctor-patient relationship and are not intended as medical advice. As with any health-related decision, we encourage you to work with your physician or other qualified health-care provider to develop an optimal personalized health management strategy.

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Conditions and Medication Responses included in the service

The Navigenics Health Compass service is dynamic; as new genetic and medical research emerges and satisfies Navigenics’ strict scientific standards, Navigenics may re-analyze your DNA to help inform you about your DNA and how it relates to new conditions, medication responses, traits, or information about your ancestry. Updates may also include new genetic and health information relevant to information you have already received. Should new updates become available, you will receive e-mail notifications and will be able to access the new information by logging on to your Navigenics Health Compass report.

You will have control over which new health conditions you are interested in receiving information about. Once you log in to your account, you can go to Manage Profile to select your condition preferences at any point. When you receive a new condition update, you will be asked whether you wish to view your results. If you choose not to receive information about a particular condition, you will be able to modify your selection at any point.

Unlike the selection process for health conditions, you will automatically be able to view any information included about medication responses. You will not be prompted to opt-in to receive that information, nor can you opt-out of receiving that information. The only exception(s) is when one or more SNPs apply to both a health condition and medication response. For example, if you choose to opt-out of learning about your genetic risk for Alzheimer’s disease, you will not see your results for statin effectiveness since the same genetic marker is used for both analyses.

Some members may not have access to all the information offered by the Navigenics Health Compass service. If you are becoming a member through an employer or other group offering or, in some cases, if you live in a state or country that has specific regulations regarding ordering or receiving genetic information, you may only receive a subset of the results available through the testing service, or you may not be able to receive automatic updates. To learn more about any specific restrictions or requirements, we encourage you to learn more prior to testing to ensure you understand the service that you will receive. If you have questions, carefully review the offering through your employer or other group, or contact Navigenics Member Service for more information.

For more information on these conditions and medication responses, please click here.

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Your results for health conditions

Based on the results of your DNA analysis, you will get two pieces of information for each condition:  First, you will receive your specific results (genotype) at each SNP that Navigenics includes in its risk estimates. Second, you will receive a “risk estimate” that tells you what your likelihood of developing each specific condition is based on the SNPs that you carry.  The risk estimates will be based on information from scientific research to calculate the following:

• How your genetic risk for each condition compares to other people in the general population
• Your estimated lifetime risk for each condition currently included within the service and whether you have an above-average, average or below-average risk of developing a specific condition during your lifetime based on your genetic data

The Navigenics Health Compass service is not a diagnostic test. Your results will not tell you whether you currently have or will definitely develop any of the conditions included in the service. With common health conditions such as those included in our service, factors such as your behavior and lifestyle contribute to your overall risk of developing the condition in addition to the genetic risk that you inherit. Our risk estimates do not account for these environmental influences.

A result indicating that you have an above average estimated lifetime risk for a specific condition merely indicates that you are likely to be genetically predisposed to that condition, and you may wish to consult your physician, consider further independent testing, or pursue genetic counseling. If you are concerned that you have, or may develop, a specific condition, additional testing through a qualified health-care provider will be required to confirm whether or not you have the condition, or any signs or symptoms of the condition. You may also wish to discuss ways to decrease your risk through changes to your behavior, lifestyle and/or medication or screening. 

A result indicating that you have an average or below-average chance of developing a specific condition during your lifetime does not guarantee that you do not have or will not develop the condition. It is important that you continue to maintain a healthy lifestyle and continue regular medical check-ups with your physician or other qualified health-care provider. Navigenics does not provide medical advice, diagnosis or treatment. You should consult your doctor if you have questions regarding any medical condition, before starting any new treatment, and before stopping any treatment that has been prescribed for you. 

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Your  results for medication responses

Based on the results of your DNA analysis, you will learn about how your genetic makeup may impact how your body processes a specific medication, should you ever require that medication. For each medication response included in the Navigenics Health Compass, your result will indicate one of the following based on the genetic markers analyzed: whether the medication is likely to be effective for you, whether you are likely to have an increased risk of side effects, or whether you have specific genetic markers that may affect optimal drug dosage.

Some medications follow complex pathways in the body in order to perform their function. The genetic markers included in this test may not represent all genetic factors that can play a role in drug response. As researchers identify new markers that meet Navigenics’ strict scientific criteria, those markers may be added to your Navigenics Health Compass report.

Other factors, not taken into consideration with your results, can also impact how you respond to a drug. Such factors include other medications or supplements you take or have taken, lifestyle, diet, and other health conditions. General information about any such factors known to impact drug response will be included in your medication response reports. Our risk estimates do not account for these environmental influences.

Regardless of any results received from the Navigenics Health Compass, you should not make any changes to medications you are currently taking or may take in the future without first consulting with your healthcare provider. Navigenics does not provide medical advice, diagnosis or treatment. You should consult your doctor if you have questions regarding any medical condition, before starting any new treatment, and before stopping any treatment that has been prescribed for you.
 

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Limitations of the DNA analysis

With regards to the accuracy of correctly identifying the SNPs that you carry, the DNA analysis performed by the testing laboratory that will process your sample is considered very accurate. There remains a small chance of laboratory error, such as your sample being misidentified by the laboratory or an error in the testing process. Accuracy of the DNA analysis also depends on several factors outside of the laboratory's control, including how carefully you follow the saliva collection instructions provided by Navigenics. Following these instructions carefully helps to ensure that your sample will arrive at the lab in a timely manner in good condition, that your sample can be identified by the unique anonymous ID number assigned by Navigenics, that your sample provides enough DNA, and that it is not contaminated with the DNA of others. 

Occasionally, there are technical problems with the test, and we will not be able to determine your result at a particular SNP even in the absence of any laboratory or sample collection errors. If our initial analysis does not provide a result for a particular SNP, Navigenics will reanalyze your DNA with the aim of achieving the most complete results possible with our service. This may, in some cases, delay the availability of your results but will not impact the accuracy if we are able to get a result. If we need additional DNA to analyze, Navigenics will request an additional saliva sample from you and repeat the genetic analysis. In some cases, due to factors beyond our control, such as factors inherent in some samples or some people’s DNA, the repeat testing will not provide additional information. In that case, the SNP will not be included in your risk estimate.

It is important to remember that even though the test can accurately report your SNP genotypes, this does not mean that the test is necessarily an accurate predictor of your risk for any health condition or trait.  Also, there are many types of genetic variations that the Navigenics Health Compass service does not test for. The service does not test for rare mutations in single genes in which having one or two specific mutations is associated with a very high likelihood of having the disease. For example, the test does not look for genetic mutations for cystic fibrosis (CFTR), or familial breast and ovarian cancer (BRCA1 and BRCA2). If you are interested in testing for these types of conditions or if you have a strong family history of any of the conditions we offer as part of the Navigenics Health Compass service (for example, if you have several family members affected with the same condition at a younger age than usual), Navigenics recommends you speak with a qualified health-care provider. Your Navigenics Genetic Counselor can help you identify how to seek out such testing services, if needed.

If Navigenics incorporates one or more additional technologies to collect or analyze genetic data in the future, Navigenics may, at its discretion, re-process your DNA sample using any such additional technology and include the results within your updated risk estimate report. However, your purchase of the Navigenics Health Compass service does not automatically include any such additional technology. You may be notified that such additional testing is available for an additional fee. You may also need to submit a new saliva sample or other biological sample for processing on such additional technology.

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Limitations of our risk estimates

The risk information provided by the Navigenics Health Compass service is based on current scientific knowledge, and this information is changing and improving over time.

• Your estimated risk for specific conditions and medication responses is based on what is currently known about genetic contributions to these conditions. Over time, new studies are likely to be published that may change your risk estimates. This means that your estimated risk for specific conditions or medication responses may be revised or refined.
• Currently, most of the published studies in this area of genetic research have focused on people of Western European descent. We do not know if, or to what extent, these results apply to people of other backgrounds.  This information will likely improve over time. 
• Our risk estimates do not account for the impact of your behavior, lifestyle, and environment on your chance of developing various health conditions. With common, complex health conditions and medication responses such as those included in our service, a combination of  genetic factors, environmental factors (such as your behavior and lifestyle), any other health conditions you may have, or medications or supplements you take or have taken, can contribute to your overall risk.

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Possible drawbacks

There are possible drawbacks related to your use of the Navigenics Health Compass service. People experience a variety of emotions after receiving information about their genetic predisposition to certain conditions. Not everyone has a strong emotional reaction, but some do. It may be difficult to know in advance how you may react to the testing process and your results. If you have been diagnosed by a health-care professional with depression, anxiety or another mental health disorder, we recommend that you consult with your health-care provider before proceeding with testing. In this case, you may choose not to proceed with testing, or you may choose to do so under the close care and supervision of a qualified health-care provider. By electing to proceed with testing, you acknowledge that you have either consulted with a qualified health-care provider or you are proceeding knowing the possible drawbacks and consequences of testing.

Some  people worry that their genetic information could be used to discriminate against them in regards to their job, or their health or life insurance. The Genetic Information Nondiscrimination Act (known as GINA) was signed into law in May 2008. This legislation offers federal protection against discrimination based on an individual’s genetic information in health insurance and employment settings. Further, the federal Health Insurance Portability and Accountability Act (HIPAA) of 1996 prohibits employers and health insurers from excluding individuals from group coverage due to genetic predisposition to certain diseases. Neither HIPAA nor GINA prohibit life insurance policies from using such information. In addition, most states have also enacted legislation intended to safeguard genetic information, but these laws vary from state to state.

• For more information on genetic discrimination, click here.
• For more information on recent efforts to enact federal legislation, click here.
• For more information on laws in your state, click here.

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Confidentiality

Navigenics will never, without your explicit consent, reveal “Your Account Information”, “Your Genetic Data” or “Your Phenotype Information” to a third party except as required to provide services you have requested, or as required by law.

• "Your Account Information" means the information that you provide to Navigenics when creating or updating your Navigenics account, or purchasing or receiving Navigenics’ services, that can be used to uniquely identify you, such as your name, telephone number, e-mail address, billing/shipping address or credit card number.
• "Your Genetic Data" means the genotyping results that Navigenics generates for you through Navigenics’ services (namely, the set of A's, G's, T's and C's at particular locations in your genome) to the extent such results are sufficient in quantity to uniquely identify you.
• "Your Phenotype Information" means the personal information that you voluntarily provide to Navigenics, which may include your gender, your birth date, your ethnicity/ancestry, the geographic regions where you or your ancestors have lived, any diseases or other health conditions that run in your family and personal traits such as height and weight.

For more details on Navigenics’ privacy and security policies and practices, please see our Privacy Policy.

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Our research

Navigenics is continuously improving the quality of our service, and we strive to contribute to scientific and medical research. To that end, we might de-link Your Genetic Data and Your Phenotype Information and combine it with other members’ information so that we can perform research to:

• Improve the quality and features of our website and services
• Provide our members with new and more accurate analysis of genetic data
• Discover or validate associations between certain genetic variations and certain health conditions or traits, as well as other insights regarding human health

As the number of our members grows, our ability to study the combined genetic data and phenotype information we have collected from our members, and to publish our findings and insights, will help us to further the advancement of scientific and medical research, with the goal of improving health care.  We will adhere to best practices in the genetics research field to ensure that any Navigenics research that is published does not disclose your identity. 

By providing your consent, you authorize Navigenics to use Your Genetic Data and Your Phenotype Information, aggregated with similar data and information from others and de-linked from Your Account Information, for these purposes.

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Storage of samples

Navigenics  reserves the right to store your saliva sample and/or the DNA extracted from your saliva during the time period in which your subscription to the Navigenics Health Compass service remains active. In addition, at Navigenics’ discretion, your stored sample may be used by Navigenics for other purposes including research (see Our Research for more details) and/or for the purposes described below in this section, unless you submit a written request to Navigenics and  except as otherwise required by law. Please call Member Service at (866) 522-1585 for instructions on how to request destruction of your saliva and DNA samples. For clarity, if Navigenics elects to store your saliva sample, and if you do not choose to purchase any additional testing services from Navigenics after the expiration or termination of your subscription to the Navigenics Health Compass service, then your sample(s) may  be destroyed at Navigenics’ discretion if permitted by law. No tests other than those described in this form will be performed on your saliva or DNA sample without your separate, explicit written consent.

While your saliva sample and/or DNA are stored at the laboratory, they may be used for the following purposes:

• To provide you with the Navigenics Health Compass service, as described above;
• Optionally, to provide you with updates and improvements to the Navigenics Health Compass service, as described above; and
• For the operation of Navigenics’ business, consistent with applicable law (including HIPAA, to the extent applicable), including activities such as quality assessment and improvement activities, training, licensing and customer service.

For more information on how Navigenics stores Your Genetic Data and Your Phenotype Information, see the Privacy Policy.

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No compensation

You understand that you will not receive any compensation as a result of having your DNA analyzed, Your Genetic Data or Your Phenotype Information analyzed or from any other research performed using Your Genetic Data or Your Phenotype Information.

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Alternatives

Your participation with Navigenics is entirely voluntary. The Navigenics Health Compass service is one of many types of genetic testing currently available. If you are interested in additional types of tests not provided by Navigenics, you can speak with your physician or other qualified health-care provider as to what may or may not be appropriate for you.

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