Journal of Allergy and Clinical Immunology 135, 100–109.e5 (2015)
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Effective Date: May 25, 2018
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These Terms and the resolution of any dispute related to these Terms or the Service shall be governed by and construed in accordance with the laws of the State of California, United States of America, without giving effect to that state’s principles of conflicts of laws. The federal and state courts of the State of California shall have exclusive jurisdiction over all claims.
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These Terms constitute the complete and exclusive statement of the agreement between the parties with respect to the use of the Service and any acts or omissions of Sun Genomics, and supersedes any and all prior or contemporaneous communications, representations, statements and understandings, whether oral or written, between the parties with respect to the subject matter thereof. You agree to abide by our Terms and not to use the Service or any part thereof in any manner not expressly permitted by these Terms. Except for the rights expressly granted to you in these Terms, Sun Genomics grants no right, title, or interest to you in the Service. Any Sun Genomics software applications of the Service are licensed, not sold, to you, and Sun Genomics and its licensors retain ownership of all copies of the Sun Genomics software applications even after installation on your personal computers, mobile handsets, tablets, and/or other relevant devices. Third party software (for example, open source software libraries) included in the Sun Genomics Service are licensed to you either under these Terms or under the relevant third party software library’s license terms as published in the help or settings section of the application and/or on our website.
Effective Date: July 23, 2018
Information We Collect
When you use our website, customer portal or other Sun Genomic related platform, such as to purchase something from our online store, we collect certain personal information from you, such as your name, address and email address, as part of the buying and selling process. We also automatically receive your computer’s internet protocol (IP) address in order to provide us with information that helps us learn about your internet browser and operating system.
How We Share Personal Information
We may share some of your personal information with our business partners or entities that perform services on our behalf. In general, the third-party providers we use will only collect, use and disclose your personal information to the extent necessary to allow them to perform the services they provide to us.
Certain third-party service providers, such as payment gateways and other payment transaction processors, have their own privacy policies for the information we are required to provide to them for your online transactions. For these providers, we recommend that you read their privacy policies so you can understand the manner in which your personal information will be handled. In particular, remember that certain providers may be located in, or have facilities that are located in, a different jurisdiction than either you or us. If you elect to proceed with a transaction that involves the services of a third-party service provider, your personal information may become subject to the laws of the jurisdiction(s) in which that service provider or its facilities are located. For example, if you are located in Canada and your transaction is processed by a payment gateway located in the United States, your personal information used in completing that transaction may be subject to disclosure under United States laws and regulations, including the USA PATRIOT Act.
We may disclose your personal information where we believe necessary to comply with legal or regulatory obligations, or if you violate our Terms of Service.
Our online store uses Google Analytics to help us learn about your store visits and the pages being viewed.
Email marketing (if applicable): We may send you emails about our online store, new products and other updates.
Our Relationship with Shopify, Inc.
Revising Your Personal Information
You may revise your personal information by going to the User Profile on our website. You may login, view and revise your personal information.
When you click on links on our online store, they may direct you away from our site. We are not responsible for the privacy practices of other sites and encourage you to read their privacy statements.
Protection of Personal Information
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Use of Our Site by Minors
By using this website, you represent that you are at least the age of majority in your state or province of residence, or that you are the age of majority in your state or province of residence and that you have given us your consent to allow any of your minor dependents to use this site.
We do not intend to invite children to visit our website and we do not knowingly collect or retain personal information from children under the age of thirteen (13). For more information on the Children’s Online Privacy Protection Act (COPPA), please visit the Federal Trade Commission website at www.ftc.gov.
If all or a portion of our business is acquired by another entity, your personal information may be transferred to one or more other entities.
Questions and Contact Information
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Project Title: Internal testing and quality assessment of extracting DNA from stool samples and suitability for use for sequencing, genotyping, and/or in an assay for microbiome profiling including detection of commercial supplier probiotic strains, human genetic variants, or microbial taxa in the sample of individuals.
PURPOSE OF THIS RESEARCH STUDY You are being asked to participate in a training and quality assessment project designed (i) to test the quality of a process and third party commercial product for obtaining and quantifying microbes from stool samples, (ii) to prove that the process works by sequencing (determining the primary structure of the DNA) the DNA (iii) further prove the viability of our supplier probiotics within our formulations. This Research Study is sponsored by and occurs within the facilities of Sun Genomics and its contractors. Most of the study will take place at the Sun Genomics facility located at 10210 Campus Point Dr. Suite 150, San Diego, CA 92121.
PROCEDURES You will be asked to provide a stool sample, to be taken at home or on-site. We will assign a unique coded identification number to your consent form and your stool sample; the coded number will be used to identify the stool sample. The consent form will be held by an individual not associated with the conduct of the study; the de-identified stool sample will be delivered to qualified personnel that shall be designated from time to time, who will provide your sample to Sun Genomics laboratory personnel. The laboratory personnel will perform the DNA extraction process on your sample and attempt to sequence your sample with the extracted DNA. Any results generated from sequencing your sample will be de-identified, so no one will know it is your sample, as explained below. Laboratory personnel may repeat the DNA extraction process and or assay one or more times on any of the stool sample that remains. Sun Genomics will retain your sample for a minimum of 1 year for follow up or confirmation of research results. The expected duration of the project is six months. The de-identified results of the Research Study will be used solely to evaluate the performance of the DNA extraction process, the quality of results obtained with the extracted DNA, and our ability to perform the procedures such as sequencing and microbiome profiling. De-identified information regarding the amount of DNA obtained from a sample may be provided to regulatory agencies in the course of CLIA Laboratory certification. This type of information does not allow the sample to be traced back to you. DNA sequence information will not be provided to a regulatory agency. Other than as stated in this paragraph, the de-identified results of the study will not be provided to anyone outside of Sun Genomics without your authorization. The de-identified results of the Research Study, including any genotyping and/or sequencing data will not be provided to you. You may receive summary information for the purpose of collecting feedback and improving the product. This Research Study is not intended to treat or diagnose, and is for quality and testing purposes only in order to evaluate a DNA extraction process for use in future, applications and our ability to use the DNA, and metagenomics analysis. Sun Genomics will not perform any monitoring of you during or after the Research Study, but you may be asked to provide follow up samples to examine changes to your microbiome profile over time.
CONFIDENTIALITY Your identity in this Research Study will be treated as confidential and we will protect this confidentiality in several ways. Your signed consent form will be maintained by a Sun Genomics team member not associated with the conduct of the Research Study and nobody else within Sun Genomics will have access to such consent form. The identification number assigned to your stool sample and to your consent form will be stored in a secure location. Only one designated person at Sun Genomics will have the link between your name and the identification number that labels your sample. The sex and race associated with your sample may be provided to the laboratory personnel for purposes of analyzing the data generated from your sample, however, this information will not allow the laboratory personnel to trace the sample back to you. If you choose to tell others about your participation in this Research Study, then Sun Genomics will still protect the confidentiality of your sample and its associated identification number. Sun Genomics will not provide or return samples or any extracts, aliquots, or derivatives to you or to any other external individuals.
POSSIBLE RISKS AND BENEFITS This Research Study involves very minimal physical risk. The likelihood of harm associated with providing a stool sample is very low and may include slight pain or discomfort, possible risk of contamination exposure, and a minimal risk of infection at the site of stool draw. The risks associated with any inadvertent disclosure of your genetic information, assay information, or sample are also low because Sun Genomics has in place procedures to protect your confidentiality, as described above, and your sample will be securely stored in the Sun Genomics repository for a minimum of 1 year. Except as stated above, you will not receive any results generated from your sample. This non-invasive procedure should have no adverse effects, but we cannot account for any existing conditions that may impact your ability to collect a sample for Sun Genomics. If, after your stool collection, you experience persistent (2+ hours) swelling and inflammation at the site, please contact your health care provider and then Stella Kramer, or equivalently qualified personnel that shall be designated from time to time, at Sun Genomics to record the issue. The study of your sample may, one day, result in a DNA extraction, analysis, or interpretation process that may be used in association with Sun Genomics product and service offerings, which may in turn benefit Sun Genomics, the scientific community and the public health. To the fullest extent permitted by applicable law, you hereby irrevocably waive all legal and equitable rights relating to all liabilities, claims, demands, actions, suits, damages, and expenses of whatever kind or nature, now known or hereafter known in any jurisdiction throughout the world (collectively, “Claims”) arising directly or indirectly from Sun Genomics, its affiliates, suppliers, vendors, contractors, subcontracts, agents, directors, officers, employees, representatives, licensees and assigns (“Released Parties”) that may result from (i) the exercise of the Released Parties’ rights under this consent, (ii) any probiotics or other materials used in connection with this project, whether provided by a Released Party or provided by any other third party, or (iii) the production, use, exhibition, exploitation, promotion, or other use of the DNA extraction process, your stool sample or results associated with your stool sample, and whether resulting in whole or in part by the negligence of a Released Party or any other person, and forever release and discharge the Released Parties from liability under such Claims. You further agree and acknowledge that you shall have no rights to any profits, royalties or any other type of compensation relating to or arising from any Sun Genomics or third party product or service offerings that may result in connection with this project and/or this consent. As a volunteer, you hereby expressly assume the risk of injury or harm from these activities and release the Released Parties from all liability for injury, illness, death or property damage resulting from the services you provide as a volunteer or occurring while you are providing services hereunder.
FINANCIAL CONSIDERATIONS You will not be compensated for your participation in this Research Study.
TERMINATION OF RESEARCH STUDY Taking part in this Research Study is voluntary and you may choose to not participate or to withdraw at any time. There will be no penalty or loss of benefits to which you are otherwise entitled if you choose not to participate or to withdraw at any time. In the event you decide to discontinue your participation in the study, please notify Suneer Jain at 619-363-5246.
AVAILABLE SOURCES OF INFORMATION If you have any questions about this Research Study, then please contact Suneer Jain at 619-363-5246. If you have any complaint about the conduct of this study, or about your treatment, you may contact Randy Socol at 858-677-1457, who is General Counsel at Sun Genomics and the Secretary who administers the Sun Genomics legal compliance.
MISCELLANEOUS This consent constitutes the sole and entire agreement between you and Sun Genomics with respect to the subject matter contained herein and supersedes all prior and contemporaneous understandings, agreements, representations, and warranties, both written and oral, with respect to such subject matter. You acknowledge and agree that you have not relied on any statement, representation, warranty, or agreement of Sun Genomics or of any other person on Sun Genomics’ behalf, except for the representations, warranties, or agreements expressly contained in this consent. If any term or provision of this consent is invalid, illegal, or unenforceable in any jurisdiction, such invalidity, illegality, or unenforceability will not affect any other term or provision of this Agreement or invalidate or render unenforceable such term or provision in any other jurisdiction. Sun Genomics may assign this Agreement and its rights hereunder, in whole or in part, to any party. This consent is binding on and inures to your benefit and the benefit of Sun Genomics and our respective heirs, executors, administrators, legal representatives, successors, and permitted assigns. All matters arising out of or relating to this consent shall be governed by and construed in accordance with the internal laws of the State of California without giving effect to any choice or conflict of law provision or rule. Any claim or cause of action arising under this consent may be brought only in the federal and state courts located in State of California, and you hereby irrevocably consents to the exclusive jurisdiction of such courts.
AUTHORIZATION I have read and understand this consent form, and I volunteer to participate in this Research Study. I understand that I will receive a copy of this form. I have had a chance to ask questions and have them answered to my satisfaction. I understand that nothing in this consent form is intended to replace or amend any Federal, state, or local laws that may apply. I represent and warrant that I am authorized to provide the informed consent set forth herein, on behalf of myself or as legal representative of the participant in this Research Study (as applicable), and hereby agree to indemnify, defend and hold harmless the Released Parties from and against any and all Claims that may arise from the failure of such representation and warranty to be, and remain during such participation in this Research Study, true.