deCODEme Genetic Scan Service Agreement and Informed Consent

Service Agreement image

  • This web page contains the Service Agreement between you – the holder of the deCODEme.com (“deCODEme”) account – and deCODE genetics ehf (“deCODE”), an Icelandic private limited company which is the provider of the deCODEme service.
  • When you click the button that says “I have read and agree to the service agreement above” it means that you agree to the terms in this service agreement and in the Terms of Use of the deCODEme.com website. It also means that you have read and understand the disclosures in this Service Agreement and in the deCODEme.com website, and decided to use the deCODEme service.

Background – Description of Genetic Scan; Purpose; Various Uses

  • The deCODEme.com service provides an analysis of genetic data measured in what we refer to as a Genetic Scan. The specification of the Genetic Scan will depend on the type of your order. Some of the Genetic Scans offered in deCODEme capture only the key genetic variants related to one or more diseases whereas a more comprehensive Genetic Scan may capture more than a million known variants across your genome.
  • A Genetic Scan can be used to learn what your DNA says about your ancestry and your body as well as whether you may have genetic variants that have been associated with higher or lower than average risk of a range of common diseases.
  • Your Genetic Scan may also let you take advantage of current scientific knowledge about disease risks associated with your genetic variations and ancestry.

Lawful use of the deCODEme service:

  • By creating an account, you warrant and confirm the following:
    • you have all necessary legal capacity under the laws of the state of your residence to enter this Service Agreement;
    • the information generated from the Genetic Scan will be used for lawful purposes only and will not be used for any business or commercial enterprise or in connection with legal disputes or to discriminate against, harm, harass, cause emotional distress to or abuse other people.
  • deCODE will not be responsible for any use or misuse of information generated from the Genetic Scan or any other information provided by deCODE to you or any information you provide to deCODE. This includes misuse by you or anyone else other than deCODE.
  • By submitting a sample for Genetic Scanning, you confirm and warrant that
    • you have the right to take and submit such sample to deCODE, and you do so freely and of your own will;
    • you authorize deCODE to process the sample
    • either you are the owner of the sample or have full authority of the owner or subject of the sample to submit the sample for processing.
    • you have complied with deCODE’s sample collection instructions.

Providing the Sample and Handling

  • To use deCODE’s personalized genomic analysis services, you must submit a buccal swab sample to deCODE for deCODE to perform a Genetic Scan on DNA purified from your sample. A buccal swab is simply a small sample of cells taken by scraping the inside of your mouth, on an absorbent base. You will receive further instructions with the kit on how to use this.
  • deCODE is not responsible for the authenticity of the samples provided for the deCODEme services and is not responsible for lost, misdirected, or damaged mail containing samples.
  • deCODE will notify you through email and messages at the deCODEme website once the sample is received and when the laboratory processing on your sample is finished.
  • Processing of the samples typically takes 2-4 weeks after their arrival and deCODE will make all reasonable efforts to process the samples within this time frame, but does not guarantee a specific turnaround time.
  • You will receive an email when the samples have been processed.
  • The sample and the DNA extracted from the sample will be stored by deCODE only for the time necessary to perform the Genetic Scan and discarded upon successful measurements. Unless you cancel your account, deCODE plans to retain the Genetic Scan data permanently.
  • If the Genetic Scan is unsuccessful because of deCODE’s error, deCODE will notify you and allow you to reorder a Genetic Scan, with a new buccal swab kit, at no additional cost.
  • Sometimes the Genetic Scan is unsuccessful even though you and deCODE did everything correctly. When this happens it is usually because the sample did not yield enough DNA or the DNA that it yielded was not pure enough. In these cases deCODE will provide you with one additional sample collection kit, at no additional cost. Subsequent reorders will only be accepted on a case-by-case basis at deCODE’s discretion.
  • If you do not comply with the sample collection instructions and reprocessing is required, you are required to pay an additional fee if deCODE requires more samples for the reprocessing.
  • deCODE may refuse to begin or complete a Genetic Scan for any person for any reason or no reason, and in such cases will refund all amounts paid unless the reason for deCODE’s refusal was your failure to follow deCODE’s instructions, your breach of this Service Agreement, or any other act or omission by you.
  • You will not be entitled to any refund unless the Genetic Scan is unsuccessful because of an error or mistake of deCODE or a laboratory processing error.

User accounts:

  • Each user account must be designated by a unique username and password. You may select any username and password at will, but deCODE reserves the right to reject a particular proposed username and/or password for any reason, including conflict with a prior user. To access any user account, the password specified by the corresponding account owner must be provided.
  • Your user account will include your username, password and other information provided by you as well as various options that you have elected on the deCODEme.com website regarding handling and sharing of information, communications and other matters. These are called your “Settings”.
  • deCODE may modify specifications for passwords from time to time, in which case you will be notified if you need to change to a new password.
  • It is your sole responsibility to assure the privacy and security of your email account and access point.
  • If you do not want to rely on email security, you can choose to disable the “forgot password” option in your Settings, i.e. the option to allow the system to mail you a password renewal or reset invitation.
  • The safety and secrecy of your password, and thereby your ability to access your account, is your own responsibility. Steps you should take include (i) monitoring and controlling access to and use of your account and password so that no unauthorized person has access to your username, password or accounts; (ii) logging out from your account at the end of each session, and (iii) promptly informing deCODE of any need to change or deactivate a password.
  • You can request to have your account canceled. To prevent accounts from being accidentally or maliciously canceled, deCODE will ask you to confirm the cancellation request via a separate email with a “terminate account” link, which will not be executed until 60 days after initiation. Within that time period you can reactivate your account. *If you terminate your account, all your data will be deleted from all the operational systems at deCODE and eliminated from all future backup restores of the operational systems. This will include your user name, password and any other information, your Settings and all information relating to your Genetic Scan. If you cancel your account before the Genetic Scan is finished, deCODE will discard your sample and not process it. If you cancel your account after the Genetic Scan is finished, deCODE will discard the scan and all other data. However, it is possible that all your data may remain stored in deCODE’s archival and backup media and systems for an indefinite time, and deCODE will not be obligated to delete this data.
  • When your Genetic Scan results are ready, deCODE will send you an email with a link to a website page. There you may view or download and save your Genetic Scan results as often as you wish while they are stored by deCODE.
  • You are responsible for access control, storage and security of all data provided by deCODE, including genotypes and analysis results of the Genetic Scan. When you receive this data in electronic form, for instance, the browser, browser settings and other settings of your computer may affect your ability to receive data from deCODE, the security of that data, and the amount of data stored on your computer. Therefore, it is your responsibility to see that your computer is adequate for this use.
  • deCODE will have no liability for losses of your data more than 3 months after your Genetic Scan. If your data is lost or irretrievably corrupted within those 3 months, deCODE will either refund the fee you paid or offer to send you a new sample kit so you can have a new Genetic Scan,
  • The initial fee you pay for the Genetic Scan includes storing your data and keeping it available for one year, subject to the foregoing limitation on our liability for loss after 3 months. deCODE reserves the right to charge an annual fee for storing your data on deCODE’s system after this first year. deCODE will notify you by email at least thirty (30) days before imposing this charge and allow you that time to download and save your data so that you may preserve it as you see fit. If you do not choose to pay for this long-term storage, deCODE will cancel your account and delete your data, as described above.

Use of your data and your samples; Who can see your Data?:

  • The visibility and access to all detailed information stored in your user account (for instance, your user name, password, email and mailing address, date of birth, gender, and ethnicity) can be specified in your Settings. You can make the information private or public to all users or only to a list of selected “friends”. Users can be found in searches, based on their public attributes. You may change your privacy settings at the deCODEme website at any time, but any changes will not obligate deCODE to make any efforts to retrieve or restrict the dissemination of information which you had previously permitted to be disclosed or shared.
  • If you disclose the results of the Genetic Scan or other personal information to others, or authorize deCODE to disclose it, it is not deCODE’s responsibility to see that these other users of your Genetic Scan or other information afford you appropriate privacy.
  • All user information and attributes you have supplied in your Settings, including your email address, are voluntarily provided by you. You can control the access of your friends and other users to these attributes through your Settings.
  • Users’ Settings, public or private, will be used by deCODE to gather statistical aggregate information about the users of the deCODEme website. Such analysis may include, but is not limited to; counting the number of users grouped by age, or associating genetic variants with any of the self reported user attributes. In the process of presenting any such statistical information, deCODE will use commercially reasonable efforts to ensure that users’ identities are not exposed.
  • deCODE will not provide any third party, including insurance companies, health management organizations, hospitals, businesses, and government agencies, access to any of your personal data or data derived from your samples unless you grant explicit authorization in your Settings or unless required to do so by law or by an order of a court having jurisdiction.
  • deCODE will treat the data created in your Genetic Scan as confidential and will only make it accessible to the user account through which the Genetic Scan and the buccal swab kit were ordered. deCODE will be entitled to assume that any person logging in through use of your user name and password is you or somebody you have authorized.
  • Payments are made through our secure payment services. Only partial credit card information will be stored in deCODE’s computer systems.
  • Through the Settings, you may specify that you do not want to appear in search listings of other users.
  • Users can accept invitations from other users to become their friends. If user A is a friend of user B then user B is also the friend to user A. Users can later remove friends from their friend list.
  • Friends see attributes from each other’s profiles based on their corresponding visibility Settings.
  • For applicable Genetic Scans, friends can compare each others’ Genetic Scan results, e.g. compare genetic sharing in 1M base genomic regions and do relationship checks.
  • Even though friends cannot view specific genotypes from each other, the possibility exists that friends can make statistical inferences about each others’ genotypes. For instance, if their relationship analysis indicates that they are twins, or they find out that a part of their genome is highly similar, they may be able to draw certain inferences.
  • You are responsible for the consequences of accepting other users as your friends.
  • deCODE may contact you through your user account and invite you to participate in research studies. You can choose not to be contacted through your email for this, but instead through a deCODEme message board. It will be your sole responsibility to check the deCODEme.com message board for these and other messages.
  • Your Genetic Scan report available via download will consist of genotype data, in tabular ASCII form, but will not include the raw data generated by deCODE’s laboratory process. deCODE reserves the right to delete this raw data from its operational system at any time. Furthermore, this data will be deleted should you terminate your account.

Interpretation of genetic analysis results:

  • Our Genetic Scans cover some or all of the following diseases and traits: Abdominal Aortic Aneurysm, Age Related Macular Degeneration, Alcohol Flush Reaction, Alzheimer’s Disease, Asthma, Atrial Fibrillation, Basal Cell Carcinoma, Bitter Taste Perception, Bladder Cancer, Brain Aneurysm, Brain Cancer-Glioma, Breast Cancer, Celiac Disease, Chronic Kidney Disease, Chronic Lymphocytic Leukemia, Chronic Obstructive Pulmonary Disease, Colorectal Cancer, Crohn’s Disease, Essential Tremor, Exfoliation Glaucoma, Eye Color, Gallstones, Gout, Heart Attack, Hemochromatosis, Hypertension, Kidney Stones, Lactose Intolerance, Lung Cancer, Male Pattern Baldness, Multiple Sclerosis, Nicotine Dependence, Obesity, Ovarian Cancer, Pancreatic Cancer, Peripheral Arterial Disease, Prostate Cancer, Psoriasis, Restless Legs Syndrome, Rheumatoid Arthritis, Systemic Lupus Erythematosus, Testicular Cancer, Thyroid Cancer, Type 1 Diabetes, Type 2 Diabetes, Ulcerative Colitis, Venous Thromboembolism. Before you access the results for any of these disease or traits, you will be given information about the nature of the disease or trait you select to and asked if you consent to view your results. Likewise, if updates or new diseases and traits are added to the deCODEme service that applies to your Genetic Scan, you will be consented and asked to accept to view your results.
  • Genetic Scan measurement is complex; utilizes specialized materials and gathers a very large amount of data. Although deCODE uses state of the art genotyping technology and high quality standards, deCODE is providing no guarantee that the Genetic Scan measurements will be successful or provide accurate results.
  • The deCODEme website will provide you with complex information, the accuracy of which depends, among other things, on the type of Genetic Scan ordered, the correctness of the Genetic Scan measurements, reported results in the genetic and the medical literature, publicly available reference data and analysis software.
  • The results provided to you by deCODEme reflect what deCODE believes to be the most accurate knowledge about genetic variants at any given time. Therefore, these results may change from time to time, based on updates of the deCODEme services and the corresponding scientific knowledge. deCODE will use commercially reasonable efforts to provide you with information on any such updates so long as deCODE has sufficient information to contact you and you have given deCODE permission to do so, but deCODE will have no liability if it does not provide such updates.
  • Some of the deCODEme services provide you with information on genetic risk that is calculated by relating your Genetic Scan measurements to relevant scientific literature regarding genetic risks. Risk estimates are only as accurate as the data used in the risk model. You acknowledge your understanding of genetic risk as a statistical measure that has implications derived from a large group of people with characteristics equivalent to yours but does not determine your chances for getting the corresponding disease, the disease severity, or the disease outcome.
  • The genetic result reported may in some cases only be applicable to a certain group of people, e.g. based on gender, ethnicity, lifestyle, family history etc. that you may or may not belong to.
  • For any given disease, calculations behind the genetic risk may not include all risk variants because (a) some genetic risk may be unknown at the time of calculation or (b) the Genetic Scan may not capture all the known genetic risk variants with sufficient accuracy.
  • deCODE has made a careful selection of the scientific findings it uses in the deCODEme service. However, such scientific findings may not be subject to approval by regulatory bodies in any country, such as the United States Food and Drug Administration or the European Medicines Agency.
  • You decide for which diseases you calculate genetic risk based on your Genetic Scan data.
  • The deCODEme.com website contains additional information about analysis and interpretation of genetic results. You acknowledge and confirm that you will read all of this information; you understand that the data you receive in your Genetic Scan cannot be properly understood without this information.

Warranty and further disclaimers

  • Some states have laws that do not permit their residents to obtain certain information regarding genetic risk provided by the Genetic Scans, unless a qualified health care professional is involved in the ordering and the delivery of results. (As of the date of publication of this Service Agreement those states are AZ, CA, CT, GA, MI, NJ, NY, PA, RI and WY. NY, MD & PA further require that laboratories providing measurements of genetic risk obtain a laboratory license issued by that state. To date deCODEme does not have a NY license). Therefore, unless the Genetic Scan is ordered under the supervision of a physician who provides appropriate counseling, the deCODEme service may omit certain genetic risk information to residents of states where providing such information is restricted (not available in NY).
  • Genetic Scans cannot be 100% accurate, and are therefore provided “AS IS” WITHOUT WARRANTIES OF ANY KIND, EITHER EXPRESS OR IMPLIED, AS TO ACCURACY, COMPLETENESS, CURRENCY OR ANY OTHER MATTER, INCLUDING WITHOUT LIMITATION, IMPLIED WARRANTIES OF MERCHANTABILITY, FITNESS FOR A PARTICULAR PURPOSE OR NON-INFRINGEMENT OF PROPRIETARY RIGHTS.
  • deCODE will not be responsible for lack of results, or errors or misleading results caused by your failure to perform the buccal swab according to deCODE’s instructions.
  • The Genetic Scan product is for informational purposes only, is not medical advice, and is not a substitute for professional medical advice, genetic counseling, diagnosis, or treatment. You must seek the advice of your physician or other qualified health provider with any questions you may have regarding the genetic aspects of a medical matter and you must not disregard professional medical advice or delay in seeking it because of the results of your Genetic Scan or anything you have read on the deCODEme Site.
  • deCODE does not recommend or endorse any specific tests, physicians, products, procedures, opinions, or other information. Reliance on the Genetic Scan or any other information provided by deCODE, deCODE employees, or other content appearing on the deCODEme site is solely at your own risk.
  • When using the deCODEme site and sending and receiving Genetic Scans and other data, information will be transmitted over a medium that may be beyond the control and jurisdiction of deCODE its suppliers. Accordingly, deCODE assumes no liability for or relating to the delay, failure, interruption, or corruption of any data or other information transmitted in connection with use of any deCODE site.
  • NEITHER DECODE, OR ITS DIVISIONS, SUBSIDIARIES, SUCCESSORS, PARENT COMPANIES, AFFILIATES OR THEIR EMPLOYEES, PARTNERS, PRINCIPALS, AGENTS AND REPRESENTATIVES, NOR ANY OTHER PARTY INVOLVED IN CREATING, PRODUCING OR DELIVERING GENETIC SCANS IS LIABLE FOR ANY DIRECT, INCIDENTAL, CONSEQUENTIAL, INDIRECT, PUNITIVE OR ANY OTHER DAMAGES ARISING OUT OF SUCH GENETIC SCANS OR YOUR USE OF THE GENETIC SCANS. THIS INCLUDES LIABILITY FOR PERSONAL INJURY OR DEATH.
  • IN NO CASE SHALL THE LIABILITY OF DECODE, OR ITS DIVISIONS, SUBSIDIARIES, SUCCESSORS, PARENT COMPANIES, AFFILIATES OR THEIR EMPLOYEES, PARTNERS, PRINCIPALS, AGENTS AND REPRESENTATIVES, NOR ANY OTHER PARTY INVOLVED IN CREATING, PRODUCING OR DELIVERING GENETIC SCANS IN CONNECTION WITH THE USE OF THIS SITE, OR ANY GENETIC SCAN OR OTHER INFORMATION EXCEED THE AMOUNT YOU PAID FOR THE GENETIC SCAN.

Remedies; Applicable Law, etc.

  • This Service Agreement shall be governed by and construed in accordance with the domestic internal laws of Iceland (without regard to conflict of laws principles). Any action you may bring in connection with this Service Agreement shall be brought solely in the Reykjavik District Court of the Republic of Iceland.
  • You agree to defend, indemnify, and hold deCODE, its officers, directors, employees, and agents harmless from and against any claims, actions or demands, liabilities and settlements including without limitation, reasonable legal and accounting fees, resulting from, or alleged to result from, your violation of this Service Agreement or your use of the Genetic Scan.
  • Any claim arising in connection with your use of deCODEme Site, or the Genetic Scan must be brought within one (1) year of the date of the event giving rise to such action occurred. Remedies under this Service Agreement are exclusive and are limited to those expressly provided for herein.
  • If any provision of this Service Agreement is found to be invalid by any court having competent jurisdiction, the invalidity of such provision shall not affect the validity of the remaining provisions, which shall remain in full force and effect. No waiver of any of these terms and conditions shall be deemed a further or continuing waiver of such term or condition or any other term or condition.

Miscellaneous

  • This Service Agreement, along with the deCODEme.com Website Terms of Use constitute the entire agreement between you and deCODE with respect to the subject matter hereof, and shall bind and inure to the benefit of the parties and their respective heirs, personal representatives, successors and assigns.
  • The provisions of this Agreement regarding Warranty and Disclaimers, Remedies, and Use of Your Data and Samples; Who Can See Your Data shall survive the expiration or termination of this Agreement for any reason whatsoever.

Last revised on April 16, 2012.

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