PATIENT AUTHORIZATION AND INFORMED CONSENT AGREEMENT
Last Updated: May 12, 2020
By clicking on the box, you, as a registered user, (“you” or “User”) are acknowledging that You have read, understand, accepted and become legally bound to the terms and conditions set forth in this this Terms of Service – Patient Authorization and Informed Consent Agreement (the “Agreement”) between Vitagene, Inc. (“Vitagene”), and you as a registered user of the online services of the website located at [https://vitagene.com/ and https://1health.io/] and other websites controlled by Vitagene (collectively, the “Site”).
You understand that Vitagene operates a digital telehealth platform that provides healthcare professionals and facilities, employers and individuals a service to obtain clinical laboratory Testing Kits for the self-collection of Samples, laboratory processing of the Testing Kit and Sample, and laboratory results through the creation of an account on the Site (“Testing Services”).
You understand that you must create or use your existing Vitagene account on the Site in order to obtain a Testing Kit and receive the Testing Services (“Account”).
- “Data” means all information collected or transmitted across the Vitagene Site, including personally identifiable information (referred to as “PII” and defined below) and personal health information.
- “Health Care Services” means the health care services to be provided by your Health Care Professional.
- “Health Care Professional” means a licensed, accredited, or certified physician, advanced practice nurse, registered nurse or other licensed healthcare professional that is providing you with Health Care Services.
- “Lab” means one of Vitagene’s designated qualified clinical laboratory partners that will receive, process, and provide results of the Testing Kit and Sample.
- “Sample” means your human specimen or tissue collected using the Testing Kit for testing and analysis at a Lab, and, where instructed to be necessary, collected under the supervision of a Health Care Professional.
- “Testing Kit” means a Sample collection device that will be processed by a Lab for the specific test and under the specific instructions set forth on Exhibit A, attached below.
Eligibility Requirements and Acknowledgements
- You are eighteen (18) years of age or older.
- Where instructed by the Testing Kit to do so or as required by law, you have been evaluated by a Health Care Professional, who determined that Service was clinically appropriate for you.
- You are engaging Vitagene under your own name and will not misrepresent your identity or impersonate another person.
- You have the legal right and ability to enter into this Agreement and receive the Testing Services.
- You are the person whose name and other information have been provided for the Account that you have created or are creating. You agree that all Samples that are sent to the Lab using the Testing Kit you receive shall be only Samples from you and no other person.
- You have secure access to personal on-line and/or mobile technology that will enable you to exchange information and communicate with Vitagene in a confidential manner.
- You are NOT experiencing a medical emergency and are not in need of immediate medical attention. IF YOU THINK YOU HAVE A MEDICAL EMERGENCY, CALL 911 IMMEDIATELY.
- You are responsible for providing accurate information and for updating any information you provide in your Account through the Site, include any requested health and medical information, location, demographic, contact information, verification of identification, or other information as determined necessary by Vitagene, in its sole discretion.
- You are responsible for completing any required information through the Site, which may include waivers, consents or authorizations, as determined necessary by Vitagene, in its sole discretion
- You understand and agree that your failure to provide accurate and complete information or to execute required documents may result in your Sample(s) not being tested, a restriction of your Account and prohibition on you from receiving further Services through the Site or Vitagene.
- You agree to follow all recommendations, protocols and other instructions provided by your Health Care Professional. You understand that, if you decide or fail to follow any of these instructions, then you will be taking an action contrary to medical advice.
- You agree to follow all Testing Kit instructions provided by Vitagene. You understand that, fail to follow the instructions may result in your Sample not being tested.
- You agree to IMMEDIATELY mail your completed Testing Kit and Sample to the designated Lab after you complete your self-collection. Please note, the Lab is independent of Vitagene. Do not mail the completed Testing Kit and Sample to Vitagene.
- Failure to ship your Sample immediately may result in your Sample not being tested.
Vitagene may provide the following Services, solely in its own discretion:
- Where required by the Testing Kit, in Vitagene’s sole discretion or as required by law, following receipt of instructions from your Health Care Professional, Vitagene will provide, sell and/or deliver a Testing Kit to you.
- Vitagene will provide a secure technology platform through the Site for you to register as a user, establish an Account, provide and update information, complete all necessary forms and documents, register your Testing Kit, and receive results of your test and other information. If your Sample is not collected in full compliance with the instructions provided by Vitagene, including the supervision by a Health Care Professional where required by Vitagene, Vitagene is entitled to discontinue the Service, including instructing the Lab to not process your Testing Kit or to provide testing results.
- Where permitted by law, Vitagene may provide you with telehealth technology to communicate with a Health Care Professional in connection with your receipt of the Testing Services, including to receive supervision on the collection of your Sample for the Testing Kit where required by Vitagene.
- Once received, our partner Lab will process the Sample for testing.
- The Lab will provide the results of your completed Testing Kit to Vitagene and your Health Care Professional for review and release to you.
- In the event Vitagene or the Lab determines that a Sample is not suitable for testing due to: (i) the content of the Sample, (ii) because you did not ship the Sample immediately upon collection, or (iii) or because we believe the Sample to have been submitted in violation of this Agreement, we reserve the right to not process the Sample, withhold the results and to not refund the cost of the Testing Services.
- Vitagene will own all Data.
- Vitagene does not provide medical advice and will not provide any services for medical emergencies or urgent situations. IF YOU THINK YOU HAVE AN EMERGENCY, CALL 911 IMMEDIATELY.
Testing Services Acceptance/Informed Consent
- You agree to abide by the obligations in this Agreement.
- You acknowledge and agree that you are making an informed decision to receive Testing Services from Vitagene through the Site and have been given all necessary and relevant information to make that decision.
- You acknowledge that Vitagene: is not a health advisor, Health Care Professional, or a testing lab, (ii) does not provide medical, health or other professional services or advice, and (iii) does not itself perform any testing on your Samples. Vitagene provides the telehealth technology via our Site for you to receive Testing Services as determined clinically appropriate by your Health Care Professional.
- You acknowledge that Health Care Professionals are not employees of Vitagene and are not providing services on behalf of Vitagene, but instead are independent professionals solely responsible for the services provided to you. Vitagene does not endorse any specific tests, physicians, health care professionals, medications, products or procedures recommended by the Health Care Professionals. You acknowledge that your reliance on any healthcare professionals or information provided by Health Care Professionals using the Site to provide you with Health Care Services, including Testing Services is solely at your own risk and you assume full responsibility for all risk associated herewith.
- In the event you receive telehealth services through the Site, you understand and agree (i) the Health Care Professional is providing Health Care Services from a REMOTE location using telehealth technology through the Site, (ii) the Health Care Services you receive via telehealth may not be as comprehensive as services you may receive in an in-person setting, (iii) you have a choice to not receive Health Care Services through telehealth, and (iv) you fully understand and accept the risks and benefits of receiving services through telehealth.
- You acknowledge and agree that you are making an informed decision to receive Health Care Services from a Health Care Professional remotely using telehealth technology, through a combination of audio, visual and store and forward technology and that such remote telehealth technology may not be appropriate for all medical issues and should not be used in emergency situations, and that you have been given all necessary and relevant information to make that decision.
- You acknowledge and agree that you are making an informed decision to receive Testing Services, including access to a Health Care Professional through telehealth technology, from Vitagene through the Site and have been given all necessary and relevant information to make that decision.
Privacy, Security, and Communication Use
- You understand that Vitagene is NOT a “covered entity” as defined by the Health Insurance Portability and Accountability Act (“HIPAA”). You understand that your Health Care Professional and the Lab are or may be “covered entities” that are subject to the provisions of HIPAA, so your health information provided to us by a Lab or your Health Care Professional may be subject to or protected by HIPAA. You agree to authorize your Health Care Professional and the Lab to obtain access and use of your health information in accordance with the Authorization attached as Addendum A to this Agreement before we can process your Testing Kit. You authorize us to provide this Authorization to your Health Care Professional and Lab and understand that the Health Care Professional and Lab may require you to execute additional documents authorizing their disclosure of your information.
- You agree that by providing electronic contact information you expressly authorize Vitagene to communicate with you via email, text, telephone, video, chat or other electronic means determined appropriate by Vitagene. You understand that such electronic communication is not a secure form of communication and you accept the risk of loss and unauthorized access or disclosure of your PII, including PHI.
Use of Your Data and Sample
- All Data collected will be exclusively owned by Vitagene
- After processing your Sample, neither Vitagene nor the Lab have any obligation or liability regarding the retention of your Sample. Any remaining Sample shall become the sole property of Vitagene or the Lab, and Vitagene or the Lab may use the remaining Sample and Data in any manner permitted by law.
- You understand and consent that by providing any Sample, having your Sample processed, or providing Data to Vitagene, you acquire no rights in any research or commercial products that may be developed by Vitagene or the Lab. You specifically understand that you will not receive compensation for any research or commercial products that include or result from your Sample or Data.
- You may access your information on the Site only through the use of a password selected by you. You are solely responsible for maintaining the confidentiality of your password, and for all activities that occur under your password. You agree to prohibit anyone else from using your password and to immediately notify Vitagene of any unauthorized use of your password or other security concerns of which you become aware.
Fees for Testing Services
- The fees for Testing Services shall be the amount indicated on the Site during the registration process or provided to you by your Healthcare Professional, and prior to your agreement to receive Testing Services.
- The amount of the fees for Testing Services appearing on the Site are subject to change from time to time and may be different than the cost charged to you by your Healthcare Professional.
- If you are responsible for paying the fees for Testing Services, you will be required to complete the payment process on the Site prior to you receiving Testing Services.
- All Sales are Final and No order may be cancelled once placed.
- Vitagene does not currently accept payment from Medicare, Medicaid, TriCare or any commercial insurance
- Vitagene accepts various forms of electronic payment for the Testing Services, including credit or debit card, pre-paid credit cards or health-savings accounts, as set forth on the Site, and are subject to change from time to time.
- Vitagene is subject to complex laws and regulations that are constantly evolving and vary from state to state. Specific billing practices and service availability may be amended periodically to comply with changes in the law or guidance from plans and regulatory authorities.
Term and Termination
- This Agreement shall commence on the date you click the box to become a User on the Vitagene Site.
- Vitagene may terminate this Agreement and your right to receive the Testing Services, through the Site, at any time, with or without cause.
- This Agreement shall terminate without notice in the event you fail to comply with the terms and conditions of this Agreement.
- Vitagene will retain any Data collected about you for as long as we are required to maintain it for any lawful purpose, including regulatory and compliance purposes, for a legal or business necessity, or for other commercial or research use.
- In the event Vitagene terminates this Agreement without cause prior to providing You the results of the Testing Service, Vitagene will provide you a full refund of any payments you have made for Testing Services to Vitagene.
Disclaimer of Warranties
- THE SITE AND TESTING SERVICES ARE PROVIDED TO YOU “AS IS, AS AVAILABLE” AND WITH ALL FAULTS AND DEFECTS WITHOUT WARRANTY OF ANY KIND. TO THE MAXIMUM EXTENT PERMITTED UNDER APPLICABLE LAW, WE, ON OUR OWN BEHALF AND ON BEHALF OF OUR AFFILIATES AND OUR AND OUR RESPECTIVE LICENSORS AND SERVICE PROFESSIONAL S, EXPRESSLY DISCLAIM ALL WARRANTIES, WHETHER EXPRESS, IMPLIED, STATUTORY OR OTHERWISE, WITH RESPECT TO THE SITE AND THE TESTING SERVICES, INCLUDING, BUT NOT LIMITED TO, ALL IMPLIED WARRANTIES OF MERCHANTABILITY, FITNESS FOR A PARTICULAR PURPOSE, TITLE AND NON-INFRINGEMENT, AND WARRANTIES THAT MAY ARISE OUT OF COURSE OF DEALING, COURSE OF PERFORMANCE, USAGE OR TRADE PRACTICE. WITHOUT LIMITATION TO THE FOREGOING, WE PROVIDE NO WARRANTY AND MAKE NO REPRESENTATION OF ANY KIND THAT THE SITE OR TESTING SERVICES WILL MEET YOUR REQUIREMENTS OR ACHIEVE ANY INTENDED RESULTS.
- WITHOUT LIMITING THE FOREGOING, NEITHER WE NOR ANY OF OUR PROFESSIONAL S, PARTNERS, AFFILIATES, OR HEALTH CARE PROFESSIONALS MAKE ANY REPRESENTATION OR WARRANTY OF ANY KIND, EXPRESS OR IMPLIED: (I) AS TO THE OPERATION OR AVAILABILITY OF THE SITE, OR THE INFORMATION, CONTENT INCLUDED THEREON; (II) THAT THE SITE OR TESTING SERVICES WILL BE UNINTERRUPTED OR ERROR-FREE; (III) AS TO THE ACCURACY, RELIABILITY, OR CURRENCY OF ANY INFORMATION OR CONTENT PROVIDED THROUGH THE SITE; OR (IV) THAT THE SITE, OUR (AND OUR SERVICE PROFESSIONAL S’) SERVERS, THE CONTENT, OR COMMUNICATIONS SENT FROM OR ON BEHALF OF US ARE FREE OF VIRUSES, SCRIPTS, TROJAN HORSES, WORMS, MALWARE, TIME BOMBS OR OTHER HARMFUL COMPONENTS.
- SOME JURISDICTIONS DO NOT ALLOW THE EXCLUSION OF OR LIMITATIONS ON IMPLIED WARRANTIES OR THE LIMITATIONS ON THE APPLICABLE STATUTORY RIGHTS OF A CONSUMER, SO SOME OR ALL OF THE ABOVE EXCLUSIONS AND LIMITATIONS MAY NOT APPLY TO YOU. You agree that we assume no responsibility for any content you submit, upload, create or make available through the Site.
Limitation of Liability; Indemnity
- TO THE FULL EXTENT PERMITTED BY LAW: (a) IN NO EVENT WILL VITAGENE, OR ITS AUTHORIZED AGENTS (EACH, A “VITAGENE PARTY” AND COLLECTIVELY, “VITAGENE PARTIES”) BE LIABLE FOR ANY INDIRECT, INCIDENTAL, SPECIAL, CONSEQUENTIAL OR PUNITIVE DAMAGES ARISING OUT OF OR RELATED TO THIS AGREEMENT, EVEN IF SUCH VITAGENE PARTY HAS BEEN ADVISED OF, KNEW OF, OR SHOULD HAVE KNOWN OF THE POSSIBILITY OF SUCH DAMAGES; AND (b) IN ANY EVENT, THE TOTAL AGGREGATE LIABILITY OF THE VITAGENE PARTIES IN CONNECTION WITH THIS AGREEMENT, FOR ALL CLAIMS OF ANY KIND (INCLUDING, BUT NOT LIMITED TO, ANY CLAIM RELATED TO THE TESTING SERVICES PERFORMED BY ANY OF THE VITAGENE PARTIES HEREUNDER OR YOUR USE THEREOF,), WILL NOT EXCEED THE AMOUNT ACTUALLY PAID BY YOU TO VITAGENE FOR THE TESTING SERVICES. THE FOREGOING LIMITATIONS WILL APPLY WHETHER SUCH DAMAGES ARISE OUT OF BREACH OF CONTRACT, TORT (INCLUDING NEGLIGENCE) OR ANY OTHER THEORY OR CAUSE OF ACTION AND REGARDLESS OF WHETHER SUCH DAMAGES WERE FORESEEABLE OR WE WERE ADVISED OF THE POSSIBILITY OF SUCH DAMAGES.
- To the extent permitted by law, you agree to release, indemnify and hold each Vitagene Party, its shareholders, owners, advisors, officers, directors, affiliates, employees, and agents harmless from all liabilities, claims, expenses arising from injury or personal damage that (i) occurs while you use the Site, (ii) your use of the Testing Services, (iii) your breach of this Agreement, (iv) arise from the Health Care Services provided by a Health Care Professional, (v) arise from your choice and use of payment method, or (vi) arise from your receipt of notices or information at your contact address or through the use of email, text or other electronic communication.
- The terms of this Agreement, and any claim or dispute relating to or arising under this Agreement or in connection with your use of the Site (each a “Dispute”), are governed by and shall be construed in accordance with the laws of the United States (including federal arbitration law) and the State of California, U.S.A., without regard to its principles of conflicts of law, or any rules of private international law, that would lead to the applicable of any other laws. EXCEPT FOR DISPUTES THAT QUALIFY FOR SMALL CLAIMS COURT, ALL DISPUTES ARISING OUT OF OR RELATED TO THIS AGREEMENT OR ANY ASPECT OF THE RELATIONSHIP BETWEEN YOU AND US, WHETHER BASED IN CONTRACT, TORT, STATUTE, FRAUD, MISREPRESENTATION OR ANY OTHER LEGAL THEORY, WILL BE RESOLVED THROUGH FINAL AND BINDING ARBITRATION BEFORE A NEUTRAL ARBITRATOR INSTEAD OF IN A COURT BY A JUDGE OR JURY, AND YOU AGREE THAT YOU AND WE ARE EACH WAIVING THE RIGHT TO TRIAL BY A JURY. YOU AGREE THAT ANY ARBITRATION UNDER THIS AGREEMENT WILL TAKE PLACE ON AN INDIVIDUAL BASIS; CLASS ARBITRATIONS AND CLASS ACTIONS ARE NOT PERMITTED AND YOU ARE AGREEING TO GIVE UP THE ABILITY TO PARTICIPATE IN A CLASS ACTION. The arbitration will be administered on an individual basis (i.e., not as a class arbitration or class action) by the American Arbitration Association (“AAA”). If you are an individual access or using the Service in your individual capacity, the arbitration will be conducted pursuant to AAA’s Consumer Arbitration Rules, as amended by this Agreement. The Consumer Arbitration Rules are available online at https://adr.org/sites/default/files/Consumer%20Rules.pdf. If you are an Organization or an individual accessing or using the Site on behalf of, or for the benefit of, an Organization, the arbitration will be conducted pursuant to AAA’s Commercial Arbitration Rules, as amended by this Agreement. The Commercial Arbitration Rules are available online at https://adr.org/sites/default/files/Commercial%20Rules.pdf.
- If you are an individual accessing or using the Site in your individual capacity, (a) the arbitrator will conduct hearings, if any, by teleconference or videoconference, rather than by personal appearances, unless the arbitrator determines upon request by you or by us that an in-person hearing is appropriate, (b) any in-person appearances will be held at a location which is reasonably convenient to both parties with due consideration of their ability to travel and other pertinent circumstances, and (c) if the parties are unable to agree on a location, such determination should be made by the AAA or by the arbitrator. If you are an Organization or an individual accessing or using the Site on behalf of, or for the benefit of, an Organization, the arbitrator will conduct hearings, if any, in-person in the County of San Francisco in the State of California, U.S.A.
- The arbitrator’s decision will follow the terms of this Agreement and will be final and binding. The arbitrator will have authority to award temporary, interim or permanent injunctive relief or relief providing for specific performance of this Agreement, but only to the extent necessary to provide relief warranted by the individual claim before the arbitrator. The award rendered by the arbitrator may be confirmed and enforced in any court having jurisdiction thereof. You agree that the federal and state courts located in the County of San Francisco in the State of California, U.S.A., will have such jurisdiction, and you hereby waive any jurisdictional, venue or inconvenient forum objections to such courts. Notwithstanding any of the foregoing, nothing in this Agreement will preclude you from bringing issues to the attention of federal, state or local agencies and, if the law allows, they can seek relief against us for you.
- This Agreement will not be governed by the U.N. Convention on Contracts for the International Sale of Goods.
- Class Action Waiver: Any proceedings to resolve or litigate any dispute in any forum will be conducted solely on an individual basis. Neither you nor we will seek to have any dispute heard as a class action or in any other proceeding in which either party acts or proposes to act in a representative capacity. No arbitration or proceeding will be combined with another without the prior written consent of all parties to all affected arbitrations or proceedings.
- Limitation of Time to File Claims: Any action, claim or dispute you have against us must be filed within one year. To the extent permitted by law, any claim or dispute under this agreement must be filed within one year in an arbitration proceeding. The one-year period begins when the claim or notice of dispute first could be filed. If a claim or dispute is not filed within one year, it is permanently barred.
- Vitagene will generally communicate with you using the email address or telephone number you provided to Vitagene. In some circumstances, we may communicate with you using the mailing address you provided to Vitagene. If you have a question or complaint regarding the Testing Services, please send an e-mail to firstname.lastname@example.org. You may also contact us by writing to 388 Market Street Suite 1300 San Francisco, CA, US, 94111. Please note that e-mail communications will not necessarily be secure; accordingly, you should not include credit card information or other sensitive information in your e-mail correspondence with us. California residents may reach the Complaint Assistance Unit of the Division of Consumer Site of the California Department of Consumer Affairs by mail at 1625 North Market Blvd., Sacramento, CA 95834, or by telephone at (916) 445-1254 or (800) 952-5210.
- Independent Contractors: The parties intend that an independent contractor relationship will be created by this Agreement, and that no additional partnership, joint venture, employee, employer or other relationship is intended. You agree not to hold yourself out as in any way sponsored by, affiliated with, endorsed by, in partnership or venture with, nor as an employee or employer of Vitagene, any of our affiliates or service providers.
- Entire Agreement: This Agreement, including the other documents referenced and referred to herein, constitutes the entire agreement between you and us with respect to the Site and the Testing Services and supersede all prior or contemporaneous understandings and agreements, whether written or oral, with respect thereto. No failure to exercise, and no delay in exercising, on the part of either party, any right or any power hereunder shall operate as a waiver thereof, nor shall any single or partial exercise of any right or power hereunder preclude further exercise of that or any other right hereunder. In the event of a conflict between this Agreement and any applicable purchase or other terms, the terms of this Agreement shall govern. If any provision of this Agreement is illegal or unenforceable under applicable law, the remainder of the provision will be amended to achieve as closely as possible the effect of the original term and all other provisions of this Agreement will continue in full force and effect. The headings of sections and paragraphs in this Agreement are for convenience only and shall not affect its interpretation.
Site © 2020 VITAGENE, INC. unless otherwise noted. All rights reserved.
Type of Testing
|1.||Covid 19 Panel Kit*|
* To the extent that any of Vitagene’s Testing Services are used by you to collect saliva specimen for purposes of detection and identification of SARS-CoV-2 RNA (the “COVID-19 Kit”), the following terms, conditions and disclaimers also apply: You are encouraged to seek and obtain medical advice from your own physician or other medical provider before using the COVID-19 Kit to discuss and understanda its proper use and utility. Failure to do so manifests the user’s agreement that he or she is solely responsible for any injury, damage, liability, cost or expense associated with the use of the COVID-19 Kit for specimen collection or otherwise, or test results derived therefrom.
Any person offering or using the COVID-19 Kit must follow the recommendations and requirements of the Food and Drug Administration Emergency Use Authorization (“EUA”) found at https://www.fda.gov/media/136875/download. By using the COVID-19 Kit, you acknowledge and agree that you have reviewed the EUA. Company does not and shall not process the collected specimens, provide laboratory services associated therewith or create test results, and bears no responsibility or liability for testing results, whether they are accurate, false positive or false negative. Nor does the Company bear any responsibility or liability for the associated services provided by any physician or other provider who orders testing or supervises specimen collection. Specimens collected are transmitted to a certified laboratory authorized under the EUA for the detection and identification of SARS-CoV-2 RNA. The EUA provides that “the SARS-CoV-2 RNA is generally detectable in respiratory specimens during the acute phase of infection. Positive results are indicative of the presence of SARS-CoV-2 RNA; clinical correlation with patient history and other diagnostic information is necessary to determine patient infection status. Positive results do not rule out bacterial infection or co-infection with other viruses. The agent detected may not be the definite cause of disease. Laboratories within the United States and its territories are required to report all positive results to the appropriate public health authorities. Negative results do not preclude SARS-CoV-2 infection and should not be used as the sole basis for patient management decisions. Negative results must be combined with clinical observations, patient history, and epidemiological information.”
I, by signing below, hereby authorize all healthcare professionals, including their physicians, their staff, agents and designees (“Health Care Professionals”) and the testing laboratories, including their physicians, their staff, agents and designees, that perform services requested by or consented to by me, to use and disclose health information about me in the manner and for the purposes stated below.
This authorization applies to the use and disclosure of the following information about me: all information in requests(s) submitted by me or about me with my consent and the laboratory test values/results/information which are the result of the request(s) so submitted.
For avoidance of doubt, I specifically authorize the transfer and release of this information to, between and among myself and the following individuals, organizations and their representatives: (a) Vitagene, Inc. and its affiliates, their staff and agents; (b) any physician that I designate, and their staff, agents and designees; (c) applicable Health Care Professionals and Labs; (d) for marketing purposes as defined by the Health Insurance Portability and Accountability Act (HIPAA), then UT Southwestern could receive direct or indirect remuneration from a third party in connection with the use or disclosure of my information. and (d) other Vitagene partners for the purposes herein, and as required or permitted by law.
The information which is the subject of this authorization will be used or disclosed for the following purposes: (a) to facilitate and execute the services requested by me or performed with my consent (including receiving, reviewing and approving a laboratory request; reviewing, processing and delivering the laboratory test value(s)/result(s)); (b) for treatment, health care operations and payment services; (c) to provide me with information and materials on treatment alternatives, health related offerings and services and products which may assist me with health, wellness and overall care or be of interest to me; (d) for marketing purposes as defined HIPAA, by Vitagene or its third-party partners, including in circumstances where Vitagene could receive direct or indirect remuneration from a third party in connection with the use or disclosure of my information; and (e) to conduct statistical research studies, and as required or permitted under state and federal laws. I may opt to not have my personal information disclosed for some purposes above with prior written notice to Vitagene as set forth below. I understand that such opt-out may affect the services I have voluntarily elected.
This authorization evidences my informed decision to allow release of the information to the parties referenced in this authorization. This authorization is effective immediately and will expire ten years after the date of this authorization.
Upon my written request, I may inspect or copy the information that I have permitted to be used or disclosed, if permitted by law. Vitagene may receive payment or other remuneration related to the use and disclosures herein.
I understand that I have a right to receive a copy of this authorization. I have the right to refuse to agree to this authorization in which case my refusal may affect the services provided to me. When my information is used or disclosed pursuant to this authorization, it may be subject to re-disclosure by the recipient and may no longer be protected by the federal HIPAA Privacy Rule. I have the right to revoke this authorization in writing at any time, except that the revocation will not apply to any information already disclosed by the parties referenced in this authorization have acted in reliance upon this authorization. My written revocation must be submitted to: Vitagene, Inc. 388 Market Street Suite 1300 San Francisco, CA, US, 94111.
If signed by someone legally authorized to represent the individual, please describe that authority and attach document(s) evidencing that authority.
By signing or acknowledging this authorization electronically, I agree to its terms and representations.
Signature: acknowledged electronically or in writing
Date: May 12, 2020
Consent for Research
Vitagene’s Consent for Research
Here at Vitagene, we are passionate about the future of healthcare.
We believe that by leveraging science and data, we can not only fulfill our mission of helping our members reach and maintain their own peak health, but we can also change the landscape of the healthcare industry. This is where you come in. Vitagene’s comprehensive suite of tests, lifestyle recommendations, and clinical input means that you’ll have a 360-degree picture of your health and a deeper understanding of what makes you, well, you. Learning what makes you so unique and, conversely, what makes you similar to others is not only fascinating; it’s also incredibly impactful, both for informing your personal wellness and for driving advancements in scientific research.
Our team of scientific researchers collects and analyzes data to discern trends, draw connections, and separate what’s working from what’s not. Our goal is to use these results to improve our supplement, lifestyle, and health recommendations and to help you reach and maintain the best health of your life.
As a Vitagene customer, you get the first opportunity to participate in our exciting research program. The consent form below allows you to opt-in to these studies and offers you all the basic details.
Here are a few answers to common questions:
Q: Is my privacy protected?
A: Absolutely. Your privacy is our number one priority.
All data used for research purposes is aggregated and de-identified. That means your identifying data is removed and that your remaining data is collected among many other data points and studied as a whole. None of your private information, such as name, address, or email, is associated with this aggregated data. Vitagene may use this collected, anonymous data to publish exciting scientific discoveries that result from your contribution (and others!).
Q: What happens if I opt out?
A: Your decision to join the research study or not does not impact any aspect of your Vitagene order, medical care, or relationship with your physician.
Q: Can I opt-in at a later time?
A: Yes! You may opt-in or out at any time. You can update your opt-in/opt-out status in your account settings. Whether or not you decided to participate in the research now, or if you decide to withdraw later, your decision will not result in any penalty or loss of benefits to which you are entitled.
Q: If I opt-in, what is expected from me?
A: Nothing! Upon opt-in, there’s nothing further you need to do to contribute to this research program.
Vitagene Protocol #001: Retrospective and Prospective Analysis of Clinical, Laboratory and Interpretative Data (VITA study)
001 WIRB® Protocol # 20152041
Dr. Reza Malek 415 Brannan Street, San Francisco, CA 94107.
If you provide your consent, your personal data will be linked to a randomly generated number and stored in our research database. There will be no direct link between your data and any published research that may come from your participation in the study. Only members of the study staff will collect the data. The data will be kept on our secure cloud services, which will be linked to each customer only via a unique study identification number. The list linking the customer and the unique study identification number will be stored on a password-protected file.
RISKS AND DISCOMFORTS
Participation in this study involves minimal risk to participants. A potential risk to customers is the highly unlikely accidental disclosure of Protected Health Information (PHI). However, all research staff have been trained on Standard Operating Procedures (SOP’s) to guide appropriate use and disclosure of PHI. Since this is only a chart review, we do not anticipate any direct risks to the customers.
This study is unrelated to your personal medical history or any related health treatments. Your condition(s) may not get better or may get worse during this study.
You will be told about any new information that might change your decision to be in this study. You may be asked to sign a new consent form if this occurs.
You will not benefit directly from your participation in this research. Customers may benefit from improvements that are made to the Vitagene supplement recommendation database as a result of this research. Additionally, customers may indirectly benefit from any discoveries made from any published research that is generated from the data we use for research.
There are no costs directly related to participation in this study.
PAYMENT FOR PARTICIPATION
You will not be paid for being in this study.
This is not a treatment study. Your alternative is not to be in this study.
SOURCE OF FUNDING FOR THE STUDY
Vitagene will pay for any costs associated with this research study.
Contact Vitagene (24 hours) for any of the following reasons:
- If you have any questions about your participation in this study
- If you have questions, concerns or complaints about the research
- If you have questions about your rights as a research subject
If you have questions, concerns or complaints about the research, you may contact:
1019 39th Avenue SE Suite 120
Puyallup, Washington 98374-2115
Telephone: 1-800-562-4789 or 360-252-2500
WIRB is a group of people who independently review research. WIRB will not be able to answer some study-specific questions, such as questions about appointment times. However, you may contact WIRB if the research staff cannot be reached or if you wish to talk to someone other than the research staff.
I have read this consent form (or it has been read to me). All my questions about the study and my part in it have been answered. I freely consent to be in this research study.
I authorize the release of my medical and research records for the purpose of this study. By signing this consent form, I have not given up any of my legal rights.
What information may be used and given to others?
The study staff will receive your personal and medical information. For example:
- Genetic information
- Research records
- Blood work information
- Lifestyle data
- Any information from fillable forms during the registration process
- Any additional fillable forms or information you provide to us during your time as a Vitagene customer
Your Credit card information, home address, and phone number will not be included as part of the research record.
Who may use and receive information about you?
The study doctor and the study staff may use your information. The research team may also use your anonymous research information for published studies in the future. The sponsor of this research may receive information about you. “Sponsor” means any persons or companies that are: working for or with the sponsor, or owned by the sponsor. Your information may also be given to: Western Institutional Review Board® (WIRB®).
Why will this information be used and/or given to others?
- To do the research
- To study the results
- To assess if the research was done right.
If the results of this study are made public, information that identifies you will not be used.
May I review or copy my information?
Yes, but only after the research is over.
May I withdraw or revoke (cancel) my permission?
You may withdraw or take away your permission to use and disclose your health information at any time. You do this by sending written notice to the study doctor. If you withdraw your permission, you will not be able to stay in this study. When you withdraw your permission, no new health information identifying you will be gathered after that date. Information that has already been gathered may still be used and given to others.
Your participation in this study may be stopped at any time by the study doctor or the sponsor without your consent for any reason, including:
- If it is in your best interest
- If you do not consent to continue in the study after being told of changes in the research that may affect you
This permission will be good until December 31, 2060.
EXPERIMENTAL SUBJECT’S BILL OF RIGHTS
California law, under Health & Safety Code Section 24172, requires that anyone who is asked to be in a research study (medical experiment), or who is asked to agree for someone else to be in a research study, has the right to know the following, in a language in which the person is fluent:
- Both the nature and reason for the research study or experiment.
- What will happen during the research study, and what drug or device will be used.
- Any expected discomforts and risks from taking part in the research.
- Any possible benefits to being in the research.
- The risks and benefits of any non-experimental medical procedures, drugs, or devices that could be used instead of being in the research.
- How research related complications will be treated during and after the research study is over.
Questions can be asked about the research and about anything that will be done during the research study. The research subject can stop taking part in the research study at any time for any reason without penalty or loss of benefits. No one can pressure, force or unduly influence any person to take part in research.
WIRB California Experimental Subject’s Bill of Rights 051310