Navigenics - Informed consent

Why Informed Consent is important

The purpose of asking you to provide your informed consent is to ensure that you understand the Navigenics™ Health Compass genome-wide scanning process. Please review the information described below before you give your consent. We want to make sure that you are aware of the benefits, limitations and potential risks before choosing to purchase the Navigenics Health Compass service.

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

• Perform a whole-genome scan on your DNA.
• 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.
• Conduct ongoing, internal research using Your Genetic Data and Your Phenotype Information, on an aggregated basis and de-linked from Your Account Information (please see below for definitions of these terms and other details regarding our 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 have the option to contribute your genetic information to science through our service, in which case you authorize us 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 (please see below for more details).

You may wish to obtain professional genetic counseling prior to providing your consent. If you have questions regarding this information and wish to speak with a Navigenics Certified Genetic Counselor, please call Member Service at (866) 522-1585.

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Description and purpose of the service

The Navigenics Health Compass service is intended to help you learn more about your genes and what they mean for your health. Using a sample of your DNA, our service scans more than 900,000 SNPs (pronounced "snips") across your genome. SNPs, or single nucleotide polymorphisms, are common, one-letter variations in the genetic code. Navigenics compares your results to reputable scientific and medical research and provides you with a personalized genetic risk estimate for specific, common health conditions and traits.

Your genes, along with your environment and lifestyle choices, play a role in the likelihood of developing certain health conditions over your lifetime. Current research in genetics is attempting to answer how DNA variations such as SNPs may be linked to various traits and health conditions. While our 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 focus your health-care needs. When your test results are ready, 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 our strict scientific standards, Navigenics will 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.

The number of health conditions included in the Navigenics Health Compass probably will continue to increase. For more information on conditions that are currently included, please click here.

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Your results

Based on the results of your whole-genome scan, you will receive your specific results (genotype) at each SNP that Navigenics includes in its risk estimates. The risk estimates will be based on information from scientific research, population studies and general population statistics to calculate the following:

• 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
• How your genetic risk for each condition compares to other people in the general population

The Navigenics Health Compass service is not a diagnostic test. Your results will not tell you whether you currently have or will develop any of the conditions included in the service. A result indicating that you have an increased estimated lifetime risk for a specific condition is merely an indication that you may be genetically predisposed to that condition and may wish to consider further independent testing, consult your physician 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.

Likewise, a result indicating that you have an average or below-average chance of developing a specific condition during your lifetime is not an indication or guarantee that you do not have or will not develop the condition. Our risk estimates do not account for environmental influences. 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. 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.

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Limitations of the genome-wide scan

The genome-wide scan performed by the testing laboratory that will process your sample is considered greater than 99 percent accurate in identifying SNPs across your genome. (This does not mean that a genome-wide scan is necessarily an accurate predictor of your risk for any health condition or trait.) However, 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 genome-wide scan 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, the test will not be able to determine your result at a particular SNP even in the absence of any laboratory or sample collection errors. Navigenics will work with the testing laboratory to repeat the analysis, but in some cases the repeat testing will not provide additional data, in which case the SNP will not be included in your risk estimate.

It is important to realize that although your genome-wide scan will analyze approximately 900,000 SNPs in your DNA, information about clinical significance is not yet available for most of these SNPs. Additional markers from your genome-wide scan will be incorporated into your Navigenics Health Compass report over time as new scientific and medical research emerges. Further, in some cases, SNPs that researchers have found to be associated with a specific health condition are not included on the testing platform used by the laboratory. In some of these cases Navigenics is able to identify a SNP included in the test that closely represents it (called a tag SNP), but in other cases no such proxy is available.

Finally, there are many types of genetic variations that the genome-wide scan does not test for. The genome-wide scan 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, 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 we incorporate one or more additional technologies to collect or analyze genetic data in the future, we may, at our 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. It is important to realize that there are many aspects of the interpretation that may improve over time as the field of genetic research advances.

• Your estimated risk for certain conditions may change over time as new SNP associations, environmental influences, population studies and general population statistics are published in peer-reviewed scientific and medical literature. In some cases, previously published SNP associations used in our risk estimates may be revised or challenged by new studies.
• The availability of genetic information representative among and across different populations will improve over time. Current risk estimates may be limited by the populations studied. For example, most of the published genome-wide association studies have focused predominantly on people of Western European descent. We do not yet have enough information to know if, or to what extent, these results can be accurately applied to people of non-Western European ancestry.
• Our risk estimates do not account for environmental influences. 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. You may experience a variety of emotions after receiving information about your genetic predisposition to certain conditions. Not everyone has an 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. 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. If you elect 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.

There is a chance that your genetic risk results could be used for reasons that are not to your benefit. 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. In addition, a majority of states have enacted legislation intended to safeguard genetic information. However, despite considerable legislative efforts, there is no federal law at this time broadly prohibiting all genetic discrimination by employers or health insurance carriers.

• 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 us when creating or updating your Navigenics account, or purchasing our 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 we generate for you through our 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 us, 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 our privacy and security policies and practices, please see our Privacy Policy.

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Our research

Continuously improving the quality of our service and contributing to scientific and medical research is an important part of Navigenics' mission. To that end, we might analyze our members' genetic data and associated phenotype information on an aggregated basis and de-linked from any member account information, to:

• Improve the quality and features of our Web site 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
• Publish our findings and insights without disclosing Your Genetic Data in a quantity sufficient to uniquely identify you, and without otherwise disclosing your identity

As the number of our members grows, it may surpass the size of currently available studies and public data sets that we use to calculate risk estimates. Our ability to study the aggregated 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.

By providing your consent, you authorize us 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

Your saliva sample will be destroyed after processing by the testing laboratory. Your DNA sample may be retained by the testing laboratory for up to one year after your saliva sample is processed, at which time your sample will be destroyed. While your sample is stored at the laboratory, it may be used for two purposes:

• To provide you with updates and improvements to the Navigenics Health Compass service if Navigenics incorporates one or more additional technologies to collect genetic data in the future; and
• To enable the testing laboratory to use the sample, on an anonymous basis only, 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 whole genome scanned, 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 the Navigenics Health Compass service, 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, we 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 we 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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