If you have any questions or concerns regarding this Policy or our Information collection or usage practices, please contact us at firstname.lastname@example.org.
If we need, or are required, to contact you concerning any event that involves this Policy or your Information we may do so using the email address, telephone number, or physical mail address we have on file for you. The parties understand and agree that Subtle has the right to amend, update and/or modify this Policy in accordance with the terms of the EULA.
Although we encourage you to read the entire Policy, the following provides a summary of some of the important aspects of this Policy:
- This Policy is applicable to Information we collect through our Platform.
- We may collect both Non-Personal Information and Personal Information through our Platform. We may also collect Personal Health Information through the Platform.
- We will not use or share Your Sensitive Personal Information (including Personal Health Information) except as permitted by this Policy.
- You are permitted to “opt out” of certain uses of your Personal Information.
- We will take reasonable and appropriate measures to secure your Personal Information, but we make no promise that your Personal Information will remain secure in all circumstances.
SCOPE OF THIS POLICY
While the Platform enables you to interact and communicate with third parties and to access and use services oﬀered by those third parties, this Policy covers ONLY Information we collect through our Platform. THIS POLICY DOES NOT COVER THE COLLECTION, USE, OR SHARING OF ANY INFORMATION BY THIRD PARTIES WITH WHICH YOU MAY INTERACT OR COMMUNICATE IN CONNECTION WITH YOUR USE OF THE PLATFORM. For information about what policies may apply to the Information you may share with any third party, please contact the third party before sharing Your Information.
INFORMATION WE COLLECT
The Information we collect through the Platform may include both “non-personal” and “personal” Information. We may also obtain “sensitive” personal health information about you or from you through the Platform. For purposes of this Policy:
“Non-Personal Information” refers to information that may not by itself be reasonably associated with, linked to, or used to individually identify you. For example, general, non-specific Information regarding your use of the Platform or derived from the Information that you provide to us through the Platform.
“Personal Information” refers to information that may be reasonably associated with, linked to, or used to individually identify an individual, a group of individuals, or your; or allow an individual, a group of individuals, or you to be personally identified or contacted. For example, Personal Information may include information such as your name, email address, telephone number, address, or credit card number, either alone or in combination with other information.
“Sensitive or Personal Health Information” refers to Personal Information regarding more sensitive areas such as medical or health conditions, precise geolocation information, or other sensitive topics.
SOURCES OF INFORMATION
We may collect Information through the Platform from a variety of sources, for example:
Directly from You. We may collect Information about you or from you directly from you when you provide Information to us through the Platform. For example, by visiting and using the Site, registering for the Platform, providing Information through the Platform, or otherwise communicating through the Platform. We may use any Information you provide to us through the Platform in accordance with this Policy.
From Third Parties. We may also obtain Information about you from third parties who have a right to provide us with that Information. For example, we may obtain Information about you from third parties that have the right to provide that Information to us. We may use any Information about you we receive from a third party in accordance with the terms we establish with that third party. Only if we combine that Information with Information we collect under this Policy will we be required to use that Information in accordance with this Policy.
Through the Operation of the Platform. We may collect Information about you or from you automatically when you interact with the Platform. For example, the Company and our third party advertisers and service providers may use “cookies,” “web beacons,” and other automated tracking technology to monitor and collect Information regarding how you access, use, and interact with the Platform. “Cookies” are commonly used small files that are stored on your computer or mobile device to help identify you as a unique user of the Platform. “Web beacons” (also known as “single–pixel” or “clear” GIFs) include electronic images imbedded in the Platform that allow us to recognize when you visit that area of the Platform.
The computers we use to provide the Platform may also automatically record Information about you or from you. For example, our web servers may record the Information you enter on the Platform, the areas of the Platform you visit, the Services you use through the Platform, your IP address, or cookies that are set on your browser. We may use any Information we collect from you automatically through the Platform in accordance with this Policy.
HOW WE USE INFORMATION
Non-Personal Information. We may use and share the Non-Personal Information we collect and obtain for any lawful business purpose without any duty or obligation of accounting or otherwise to you, provided that the Information remains Non-Personal Information. This will include, by way of example, sharing that Non-Personal Information with third parties or developing products, services, and other oﬀerings based on the Non- Personal Information and providing those oﬀerings to other users and third parties.
Personal Information. We may use the Personal Information we collect about you or from you for a variety of purposes, for example:
- Operating the Platform;
- Providing Services to you through the Platform;
- Customizing and improving the Platform and Services for you; Providing maintenance, support, and customer service for the Platform;
- Providing advertising through the Platform;
- Providing notices and announcements to you relating to the Company, the Platform, or your Information;
- Providing oﬀers for Products, Services, or other oﬀerings that we feel may be of interest to you; Contacting you for direct marketing purposes;
- Processing payments made through the Platform; Developing additional Products, Services and oﬀerings; and Research and analysis.
We may combine and enhance the Personal Information we collect and obtain about you or from you with Information we receive from third parties, provided that we use the combined Information in accordance with this Policy.
We may also use the Personal Information we collect and obtain about you or from you to generate Non-Personal Information. When we do so, we will take reasonable measures to ensure that the Non- Personal Information is no longer personally identifiable and may not later be reasonably associated with, linked to, or used to identify you. This will include, by way of example, storing the Non-Personal Information separately from any Personal Information. Once we generate Non-Personal Information from any Personal Information, we will not later attempt to again make that information personally identifiable. However, we may combine and enhance that Non-Personal Information with other Non- Personal Information we receive or obtain third parties.
You should not provide any personal information to us, whether via the Platform or any Services, unless you agree to the use of that Information in accordance with this Policy.
Sensitive Personal Information. The Information we collect and obtain regarding you may include Sensitive Personal Information. For example, when you share Sensitive Personal Information in communications with us through the Platform. Company will use any Sensitive Personal Information about you or from you that we receive solely in accordance with this Policy to enable the operation of the Platform and the Services you ask us to provide to you. Note though that Company is not responsible for monitoring the Sensitive Personal Information you may exchange with others through the Platform or for the use of that Information by other third party with whom you share that Information.
HOW WE SHARE INFORMATION
We may share Information about you or from you in a variety of ways, for example:
Affiliates. We may share Information with companies that we own or control, that are owned or controlled by us, or that are under common ownership or control with us.
Business Partners. We may share Information with business partners for which we collect Information through the Platform. We will work with our business partners to provide notice to you concerning the purpose for which any Personal Information is being collected on behalf of any business partner. Unless we otherwise notify you, any information we collect on behalf of a business partner will be in accordance with this Policy.
Service Providers. We may share Information with third parties that help us provide the Platform and our Services. For example, we may use third parties to: (a) host, maintain, or manage the Platform or our Services; (b) collect or analyze Information; (c) customize or assist us in managing our databases; or (d) provide other Services relating to the Platform. We require that these third parties agree to use the Information we share with them only to perform their obligations to us and to treat all Personal Information they receive from us in compliance with this Policy.
Other Entities. We may share Information with third parties so that they may develop and oﬀer additional products and Services to you that we believe will be of interest to you based on the Information we collect and obtain about you or from you. Law Enforcement. We may share Information with law enforcement agencies if we reasonably believe unlawful activities have occurred or the Information may aid in an investigation into unlawful activity. We may also share Information with law enforcement if we determine, in our sole judgment, that you have violated our agreements or policies or that the release of your Information may protect the rights, property, interests, or safety of Company or any third party.
Legal Processes. We may share Information as required by, or permitted by, law, whether in response to subpoenas, court orders, other legal processes, or as we believe is necessary to exercise our legal rights, including to defend against legal claims that have been or might be brought against us.
Business Transactions. If we transfer ownership or control of any portion of Company or the Platform to a third party, whether or not in the context of an acquisition, merger, or reorganization, we may transfer Information that third party, provided that the use of any of your Personal Information by that third party remains subject to the terms of this Policy.
CHOICE AND OPT-OUT
We may give you the opportunity to “opt-out” of having your Personal Information used or shared for certain purposes otherwise permitted by this Policy. For example, we may provide you with a choice whether to receive certain messages through from us, whether through the Platform or through other means.
If you no longer wish to receive certain messages from us or to have your Personal Information shared in the manner otherwise permitted by this Policy, you may seek to opt- out of receiving those messages or having your Personal Information shared in that manner. In some cases, opting out of receiving messages or having your Personal Information shared will not aﬀect your ability to use the Platform or the Services we provide through the Platform. However, some messages are necessary to the use and operation of the Platform.
Likewise, some sharing of Personal Information is necessary to provide you with the Services we oﬀer through the Platform. If you wish to opt-out of receiving these messages or of sharing your Personal Information in this manner, we may be required to limit or cancel your access to the Platform or our Services.
All opt-out requests can be made as indicated through the Site or contacting the Company as described above. Note that it may take up to ten (10) business days to remove contact information from our lists, so messages from us may continue for a time after a removal request is made.
We are committed to protecting and securing your Personal Information. Despite our commitment, no security system can be 100% eﬀective and we cannot guarantee that your Personal Information (or any other Information) will be secure in all situations. We will nonetheless take all reasonable and appropriate steps to insure the safety and security of your Personal Information. This includes using industry standard security measures to protect the loss, misuse, and unintended alteration of the Personal Information under our control. For example, our policy is that only those individuals who need your Personal Information to perform a specific job for us are granted access to that Personal Information. Likewise, all employees and contractors are kept up-to-date on our security and privacy practices. Finally, the servers that we store personally identifiable information on are kept in a secure environment.
Children. The Platform and our Services are not directed to children under 18 years of age. The Company does not knowingly solicit or collect personal information from children under 18 years of age.
Do Not Track. Certain web browsers and other devices you may use to access the Platform may permit you to indicate your preference that you do not wish to be “tracked” online. At this time we do not modify your experience on the Site or the Platform, or the Information we collect from you through the Site or Platform, based on whether such a preference is indicated.
Review and Update of Information. While the Company takes reasonable steps to ensure that the Personal Information we collect from you is reliable for its intended use, accurate, complete, and current, we rely on you to update and correct your Personal information. Please contact us as described above to review, update, or change any of the Personal information we have on file for you.
We have adopted a policy of allowing you to opt-out of the disclosure of your Personal Information to third parties for direct marketing purposes and thus fall within this exception. Instructions for opting out can be found in the section of this Policy entitled “Choice and Opt-Out.”
Notification of Changes. We may notify you of any changes to this Policy by way of an email, by posting on the Site or through the Platform. Changes to this Policy will be eﬀective 30 days following such notice. Your continued use of the Site or other aspects of the Platform after any change has become eﬀective will constitute your acceptance of that change. Unless we seek and receive consent from you, we will use the Personal Information we collect and obtain about you or from you in accordance with the version of this Policy eﬀective when the Personal Information was last collected.
UPDATED NIH FCOI POLICY
UPDATED Subtle Medical-wide Policy: Government Awards Financial Conflict of Interest Disclosures
Updated On: July 1st , 2021
Next Review Date: June 28, 2024
Approval Date: July 3rd , 2021
Approved By: Enhao Gong, PhD
SCOPE: Company Wide. The Government Awards Compliance Program (Program) covers all projects conducted with government funds in Subtle Medical and is applicable to all employees, sub recipients, consultants, or any other covered organizations or persons involved in governmental awards.
PURPOSE: Under this policy, Subtle Medical strives to ensure that all work performed under Government Awards meets the highest standard of integrity and is free of any real or perceived conflicts of interest that could harm patients, the reputation of Subtle Medical, the governmental agency providing the funding, and/or external partners. As Subtle Medical must comply with government regulations when making expenditures with Government Awards, this policy governs the disclosure of individual financial interests and the management and reporting of individual financial conflicts of interest in Governmental Awards. It is intended to comply with the requirements of federal regulations, including , but not limited to, the conflict of interest regulations of the U.S. Department of Health and Human Services Public Health Service (“the PHS FCOI Rules”) as found in 42 CFR Part 50 Part F (titled Promoting Objectivity in Research) and 45 CFR Part 94 (titled Responsible Prospective Contractors) and the Federal Acquisition Regulation FAR 52.203-16 (collectively referred to as the “Financial Conflict of Interest Rules”).
Conflict Management Plan: the document specifying the actions to be taken to manage a Financial Conflict of Interest.
External Partner: a consultant, subcontractor, or sub-recipient performing work under a Government Award who is not employed by Subtle Medical
Government Award: government grants and cost reimbursement contracts including research grants or contracts, and other types of government financial assistance (e.g., cooperative agreements, loans, loan guarantees, property, donated supplies, and direct appropriations) that Subtle Medical receives directly from government agencies or indirectly from pass through entities. (At Subtle Medical, Government Awards are commonly referred to as “Sponsored Projects.”) Government Awards do not include procurement contracts, payments for health care services provided under government health care programs (e.g., Medicare, Medicaid) or Medical Education and Research Costs (MERC)).
Financial Conflict of Interest (FCOI): a significant financial interest that could directly and significantly affect the design, conduct, or reporting of a research study or other government funded project.
Immediate Family Member: a spouse, domestic partner, child or step-child, parent or step-parent, or sibling or step-sibling.
(1) For PHS-funded research: the project director or principal Investigator and any other person, regardless of title or position, who is responsible for the design, conduct, or reporting of research funded by the PHS, or proposed for such funding, which may include, for example, collaborators or consultants.
(2) For other Government Awards: project staff directly involved in management of the project or who hold key responsibilities on the Government Award. Typically, these would be individuals specifically named to a Government Award or whose participation is key to the success of the project.
Institutional Responsibilities: An Investigator’s professional responsibilities on behalf of Subtle Medical, which may include, but is not limited to: research, research consultation, teaching, professional practice, institutional committee memberships, and service on panels such as Institutional Review Boards or Data and Safety Monitoring Boards.
Public Health Service (PHS): a division of the Department of Health and Human Services, consisting of the following agencies: Agency for Healthcare Research and Quality (AHRQ), Agency for Toxic Substances and Disease Registry (ATSDR), Centers for Disease Control and Prevention (CDC), Food and Drug Administration (FDA), Health Resources and Services Administration (HRSA), Indian Health Service (IHS), National Institutes of Health (NIH), and Substance Abuse and Mental Health Services Administration (SAMHSA).
Research: a systematic investigation, study, or experiment designed to develop or contribute to generalizable knowledge relating broadly to public health, including behavioral and social-sciences research.
Remuneration: salary and any payment for services not otherwise identified as salary (e.g., consulting fees, honoraria, paid authorships).
Significant Financial Interest:
(1) A financial interest consisting of one or more of the following interests of the Investigator or their Immediate Family Member that reasonably appears to be related to the Investigator’s Institutional Responsibilities:
(i) the value of any remuneration received from a public entity in the twelve months preceding the disclosure and the value of any equity interest in the entity as of the date of disclosure, when aggregated, exceeds $5,000; or
- (ii) the value of any remuneration received from a non-publicly traded entity in the twelve months preceding the disclosure, when aggregated, exceeds $5,000, or when the Investigator (or their immediate family) holds any equity interest (e.g., stock, stock option, or other ownership interest); or
(iii) Intellectual property rights and interests (e.g., patents, copyrights), upon receipt of income related to such rights and interests.
(2) Investigators must disclose the occurrence of any reimbursed or sponsored travel related to their Institutional Responsibilities. The disclosure will include, at a minimum, the following details: (i) the purpose of the trip; (ii) the identity of the sponsor/organizer; (iii) the destination; and (iv) the trip duration. (This disclosure requirement does not apply to travel that is reimbursed or sponsored by a federal, state, or local government agency, an Institution of higher education, an academic teaching hospital, a medical center, or a research institute that is affiliated with an Institution of higher education.)
(3) A significant financial interest does not include the following:
- Salary, royalties, or other remuneration paid by Subtle Medical to the Investigator if the Investigator is currently employed or otherwise appointed by Subtle Medical;
- Intellectual property rights assigned to Subtle Medical and agreements to share in royalties related to such rights;
- Income from investment vehicles, such as mutual funds and retirement accounts, as long as the Investigator does not directly control the investment decisions made in these vehicles;
- Income from seminars, lectures, or teaching engagements sponsored by a federal, state, or local government agency, an institution of higher education as defined in 20 U.S.C. 1001(a), an academic teaching hospital, a medical center, or a research institute that is affiliated with an institution of higher education; and
- Income from service on advisory committees or review panels for a federal, state, or local government agency, or an Institution of higher education as defined at 20 U.S.C. 1001(a), an academic teaching hospital, a medical center, or a research institute that is affiliated with an institution of higher education.
It is the policy of Subtle Medical to comply with the Financial Conflict of Interest Rules (“FCOI Rules”) to ensure that the work performed under Government Awards is carried out in a manner that is free from any bias which may result from financial conflicts of interest. All Investigators for Government Awards must disclose any Significant Financial Interests (SFI) to Subtle Medical. Investigators must complete or update a disclosure survey at least annually during the period of the award and must disclose any new SFI’s within thirty days of discovering or acquiring the SFI. Investigators also must ensure that the disclosure survey is completed or updated no later than the time of application for a Government Award.
If Subtle Medical determines that a SFI constitutes a Financial Conflict of Interest (“FCOI”), Subtle Medical will establish and monitor a Conflict Management Plan (“CMP”) to manage or eliminate the conflict of interest. The manager of Sponsored Projects Administration (SPA) will be the conflict of interest official responsible for managing the conflict of interest process for Government Awards. No Government Award funds may be expended unless the SPA Manager has determined that no FCOI exists or that any FCOI is manageable in accordance with the terms of a CMP that has been adopted and implemented in accordance with the procedures set forth in this policy.
Duty to Cooperate
If the conflict of interest official requests additional information from an Investigator to assess whether a SFI constitutes a Financial Conflict of Interest, (including but not limited to documents relating to the SFI), the Investigator must cooperate with the request. If a CMP is implemented in connection with a SFI, the Investigator must comply with the CMP. Compliance with the requirements of this policy is a condition of employment with Subtle Medical for employed Investigators and a condition of participating in Government Award projects as an External Partner. Failure to comply may result in appropriate sanctions.
Investigators must complete training regarding this policy and the applicable regulations at the following times: (i) upon becoming an Investigator for Subtle Medical; (ii) before performing work under a Government Award; (iii) when this policy is revised to alter the responsibilities of an Investigator;(iv) and at least every four years.
Public Posting of Policy
This policy will be posted on a publicly accessible Internet site for Subtle Medical.
Reporting of Financial Conflicts of Interest for PHS-Funded Projects
Before the expenditure of any funds under a PHS-funded project and within sixty days of subsequently identifying a Financial Conflict of Interest, the SPA Manager will report all Financial Conflicts of Interest that have not been eliminated to the PHS awarding component and will ensure that an appropriate Conflict Management Plan has been implemented. The report will include the elements required under the PHS FCOI Rules. For subsequently identified FCOI’s, the SPA Manager will conduct a retrospective review to determine whether the PHS-funded project was affected by the financial conflict of interest, and if bias is found, will submit a mitigation report to the PHS awarding component. The SPA Manager also will provide an annual FCOI report that addresses the status of any previously reported FCOI’s and CMP’s related to an ongoing PHS-funded project.
Any individual or organization acting as a consultant, subcontractor, or subrecipient (“External Partner”) to Subtle Medical on a PHS-funded award must either: (1) have a FCOI policy that meets the requirements of the PHS FCOI Rules or (2) follow this policy.
- Organizations with their own policy will certify that the policy meets the requirements of the PHS FCOI Rules by submitting an External Partner Financial Conflict of Interest Disclosure form or registering with the FDP Clearinghouse [insert link] before submission of the Government Award. The SPA Manager will verify registration with the FDP Clearinghouse before submission. The contract with Subtle Medical will contain language requiring compliance with the organization’s FCOI Policy.
- Individuals and organizations without their own FCOI policy are required to follow this policy. The contract with Subtle Medical will contain language requiring compliance with Subtle Medical’s Government Awards FCOI Policy.
This procedure is for use by Subtle Medical employees and External Partners that do not have their own FCOI policy.
- Before the expenditure of funds under a Government Award, Investigators must complete the training on Subtle Medical’s Government Awards FCOI Policy. All external investigators must complete FCOI training required under the policy. Training can either be completed using the NIH FCOI tutorial found at: https://grants.nih.gov/grants/policy/coi/tutorial2011/fcoi.htm or CITI COI training found at: https://about.citiprogram.org/en/homepage/ .
- Training must be documented by submitting the Government Award FCOI Training Certification form to Subtle Medical Sponsored Projects Administration. The required training is valid for four years; however, Investigators are required to certify annually that they understand and have complied with their responsibilities under Subtle Medical’s Government Awards FCOI Policy.
- After the training is completed, the Investigator will complete the Government Award FCOI Questionnaire. This survey must be completed no later than the time of application for a Government Award and before any funds are expended. It also must be updated as required by the policy.
- The principal investigator/project director will complete the Government Award Approval form, which requires verification that those meeting the definition of Investigator and External Partners have been informed of the requirement to comply with this policy.
- The Investigator must report and update their Government Award FCOI Questionnaire when he/she is a recipient of sponsored travel. The Investigator will disclose: the purpose of the trip; the name of the entity that paid for the travel; the travel destination; the duration of the trip; the dates of the travel; and if known, the approximate value of the Sponsored Travel.
- If the SPA Manager determines a FCOI exists, he/she will create a draft CMP. The draft CMP will be presented to the Research Compliance Oversight Committee (RCOC) for consideration and approval. The RCOC will act as the Conflict of Interest Committee for purposes of Government Awards.
- The actions taken by the RCOC will be documented in the RCOC meeting minutes. The SPA Manager will ensure that CMP’s are properly implemented and will monitor compliance with CMP’s on an ongoing basis. The RCOC will review the status of established CMP’s at intervals determined by the RCOC and indicated in the CMP, and will have oversight responsibility for the enforcement of CMPs and compliance with this policy.
- Each Investigator under a CMP must comply fully and promptly with the CMP, and each person identified in the CMP as having responsibility for monitoring compliance with the CMP must carefully and fully monitor that compliance.
- For PHS-funded projects, SPA will disclose the FCOI and CMP to the PHS awarding component before the expenditure of any federal funds.
- For PHS-funded projects, Subtle Medical will be make FCOI information available to those who submit a request by sending an email to aralegil@Subtle Medicalinc.com or by writing SPA at the address below. Responses will be sent within five business days.
- Subtle Medical will keep records related to FCOI and the related CMP for the longer of at least three years after:
- the date of creation;
- the date of termination or completion of the Government Award and submission of the final expenditure report for the Government Award identified in the disclosure statement;
- the date of final resolution of any investigation, audit, or similar action involving the records; or
- the date required to be in compliance with Subtle Medical’s Record Retention policies.
- RCOC will regularly evaluate compliance with this policy and will review the effectiveness of SPA’s conflict of interest management program, including a review of the implementation and effectiveness of these procedures.
SPA Procedure for External Partners with their own PHS Rule policy
- The principal investigator/project director will complete the Government Award Approval form, which requires them to inform any External Partner if they need to comply with FCOI Rules.
- Prior to any application submitted by Subtle Medical for a Government Award, SPA must receive confirmation the External Partner has a FCOI policy that meets the PHS FCOI Rules.
- The External Partner will have two options to verify they have a FCOI:
- Register with the FDP Clearinghouse, https://fdpclearinghouse.org/ . At this time, this website is acting as a central registration location for many colleges. Subtle Medical will accept this method of verification. Registration is free and you may contact SPA if you have questions.
- Submit the External Partner Financial Conflict of Interest Disclosure.
Enhao Gong, PhD
Subtle Medical In.
883 Santa Cruz Ave, Suite 205,
Menlo Park, CA, 94025Email: email@example.com