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 assessed (see “Conditions 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 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. 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, knowing about genetic risk factors can serve as a tool to help you and your physician focus 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.  Using a saliva sample to collect a sample of your DNA, Navigenics analyzes certain SNPs in your DNA – SNPs that have already been reported in reputable scientific and medical journals as being associated with a higher chance of having the health conditions included in the Navigenics Health Compass service – in order to provide you with a personalized genetic risk estimate for these health conditions.

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. 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 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 and add new conditions, traits or information about your ancestry to your Navigenics Health Compass report. You will receive e-mail notifications when such updates are available. Updates may also include new genetic and health information relevant to information you have already received.

You will have control over which new 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.

For more information on these conditions, please click here.

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Your results

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. n or other qualified health-care provider.

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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 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 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 such as those included in our service, both genetic and environmental factors (such as your behavior and lifestyle) contribute to your overall risk of developing the condition.
   

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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 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. HIPAA does not prohibit life insurance policies from using such information. Most states have also enacted legislation intended to safeguard genetic information, but these laws vary from state to state. In addition, the Genetic Information Nondiscrimination Act was signed into law in May 2008.  This legislation will offer federal protection against discrimination based on an individual’s genetic information in health insurance and employment settings.  The parts of the law relating to health insurers will take effect by May 2009, and those relating to employers will take effect by November 2009.

• 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.

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, 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 the DNA extracted from your saliva for up to one year after your sample is processed. If Navigenics elects to store your saliva sample, and if you do not choose to purchase any additional testing services from Navigenics during that year, then your sample will be destroyed at the end of that year. For clarity, 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 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; and
• To enable the testing laboratory to use the sample for its internal laboratory quality purposes, such as determining how long stored DNA remains usable and reliable or whether stored DNA can be accurately scanned using other existing and/or future technologies.

For more information on how Navigenics stores Your Genetic Data and Your Phenotype Information, please 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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Contribute your genetic information to science

You also have the opportunity to participate in scientific research by contributing Your Genetic Data and Your Phenotype Information (de-linked from Your Account Information) obtained through the Navigenics service. If you choose to contribute your information, you allow:

• Navigenics to share your genetic information with not-for-profit organizations that perform genetic or medical research.
• The not-for-profit organizations to separately or jointly publish study results that include Your Genetic Data and Your Phenotype Information (but not Your Account Information), in peer-reviewed scientific and medical journals and otherwise, and to deposit such data and information into public data repositories or otherwise make them publicly available to the extent required by such journals.

You are free to choose not to contribute your genetic information to science through the Navigenics service at this time. If you elect not to contribute your genetic information to science through the Navigenics service, Navigenics will not share Your Genetic Data or Your Phenotype Information with such organizations. Moreover, declining to contribute does not in any way affect the nature of the service Navigenics will provide you.

If you choose to contribute your genetic information to science through the Navigenics service, you may at any time in the future withdraw your consent for not-for-profit organizations to begin new studies using Your Genetic Data and Your Phenotype Information. Such withdrawal of your consent shall be effective within 90 days after you change your Navigenics member profile accordingly. However, Your Genetic Data and Your Phenotype Information will not be withdrawn from any ongoing or completed studies or publications in which Your Genetic Data or Your Phenotype Information were utilized because your genetic information will be coded and not able to be identified.

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