Author(s): Web Vision Technologies Management Team
Introduction and Company Overview
Web Vision Centers Group, LLC (DBA Web Vision Technologies) is a Utah based company that develops vision care technology through research and product development. This is accomplished through the use of internal resources and sometimes external resources, such as consultants, advisors, and other companies that have a specific skillset and technology that would be relevant to various projects Web Vision Technologies is working on.
Web Vision Technologies (Web Vision) is currently developing vision care technology that might be used by National Aeronautics and Space Administration (NASA) for the space program and sometimes we receive funding through grants from External Funding Sources (EFS) such as Translational Research Institute (TRISH) for Space Health (https://www.nasa.gov/hrp/tri) . As a recipient of this funding, it is Web Vision’s desire and management’s directive to fully comply with all Federal Regulations relating to institutions or individuals receiving government funding (such as those found at https://grants.nih.gov/grants/policy/coi/index.htm).
Web Vision is also planning to commercialize some of this vision care technology that could potentially be used by eyecare professionals, healthcare providers, and non-profit groups. Web Vision has not received to date any additional outside funding, such as institutional investors or private/public companies.
Web Vision Technologies strives to create a research and product development climate that promotes objectivity in all matters relating to research and product development by establishing these standards and policies such that the design, conduct, and reporting of all grant funded (government or private) research and product development is free from bias resulting from a Financial Conflict of Interest (FCOI) [see definitions below]. Web Vision has named a FCOI Compliance Administrator to insure the company is in compliance with this policy and to help manage any situations where non-compliance becomes an issue (See IV. Administrative section below).
Who is Affected by This Policy? This policy is applicable to each employee, consultant, advisor and/or company doing subcontractor work for Web Vision (collectively Worker) and who is planning to or is participating in research activity that is either partially or wholly supported by EFS’s, such as government funded grants.
Each such Worker must:
1. Disclose his or her Significant Financial Interests (SFI), see definitions below, in non-Web Vision entities that would appear to be related to the employee’s professional responsibilities (FCOI Disclosure Form);
2. Comply with a FCOI management plan, if a FCOI is identified; and
3. Undergo FCOI training, at least once every four years.
Disclosure of SFI is essential for Web Vision to determine if a FCOI exists and in cases of FCOI determine how it will be managed and reported in full compliance with government regulation. Non-disclosure of SFI or non-compliance with FCOI management plan may subject the Worker to discipline including, without limitation, suspension or termination of employment and or termination of the contract with Web Vision.
A. Financial conflict of interest (FCOI) means a significant financial interest that could directly and significantly affect the design, conduct, or reporting of outside funded research/product development.
B. Significant Financial Interest (SFI) exists [*A] if the value of remuneration received by the Worker, Worker’s spouse or dependent children that reasonably appear to be related to the Worker’s Web Vision responsibilities [*B] exceeds $5,000 annually;
*A. SFI disclosure also includes travel. Specifically, externally funded reimbursed or sponsored travel that would appear to be related to employee’s Web Vision responsibilities, however, that is not funded by Web Vision. Such travel must be disclosed (if the amount exceeds $5,000 annually) except when the expenses are covered by any of the excluded sources. The amount of the expenses does not need to be disclosed, just the fact that they exceed $5,000 annually.
*B. Worker’s professional responsibilities on behalf of Web Vision means conducting research, submitting patent applications, publication, technical committee membership and, teaching as adjunct faculty at an Institute of higher education.
*C. An excluded source means a source of remuneration that is excluded from disclosure. With reference to the SFI, excluded sources are – 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.
What do Workers Need to Do (SFI Disclosure Procedure) Workers who are planning to or currently participating in research or product development activities for Web Vision that are either partially or wholly supported by EFS’s must disclose their SFI in a timely fashion*, either to a member of the Web Vision Technologies Management Team (WVT MT) or the designated Web Vision FCOI Compliance Administrator.
*New Workers must complete the FCOI training within 10 days of employment or contract inception and complete a FCOI Declaration Form within 30 days (and annually after that or within 30 days of a change in their SFI status, as outlined in this policy).
The designated Web Vision FCOI Compliance Administrator will determine whether the SFI constitutes an FCOI, based on guidance set by the WVT MT, government regulations, and this policy. Consistent with the Protocol for Handling Financial Conflict of Interest, if the SFI is determined to be an FCOI, the WVT MT (working with the FCOI Compliance Administrator) will take actions to discuss, determine, and approve the implementation of an FCOI management plan consistent with this policy and, furthermore, to promptly notify the Web Vision’s EFS (e.g., TRISH) via a FCOI report within 30 days of development of the plan.
As a part of the FCOI management plan, the WVT MT will decide one or more actions depending upon the situation, including (but not limited to) requiring certain disclosure in public presentations, situation oversight by the FCOI Compliance Administrator or external body appointed by the WVT MT, or other actions as agreed to by Web Vision and the outside funding source (i.e. TRISH). Workers with an identified FCOI must comply with the FCOI management plan.
The designated Web Vision FCOI Compliance Administrator is responsible for administration and oversight of this policy. The FCOI Compliance Administrator will be a qualified external (non-Web Vision employee) person that will be selected by WVT MT, with input from the major EFS (i.e. TRISH). The current Web Vision FCOI Compliance Administrator with contact information will be listed on the Web Vision Technologies website (www.WebVisionTechnololgies.net)
V Protocol for Handling Financial Conflict of Interest
1. Review of Disclosures
All FCOI Disclosure Forms, including those submitted by a new Workers who joins an ongoing EFS project, will be reviewed by the designated Web Vision FCOI Compliance Administrator. All disclosures should be submitted on a FCOI Declaration Form. The review will determine whether an SFI is related to the EFS research/project development project and therefore an FCOI. The designated FCOI Compliance Administrator may involve the relevant investigator in the review and request additional information from the investigator.
When an SFI that was not disclosed by a Worker in a timely manner is identified, the designated Web Vision FCOI Compliance Administrator will determine if FCOI exists, develop and implement a management plan within thirty (30) days after the identification of the SFI. In addition, the designated FCOI Compliance Administrator will conduct a retrospective review of SFIs for the Worker(s) within one hundred twenty (120) days and document it.
2. Management of FCOI
For each disclosure that leads to determination of FCOI, the WVT MT will discuss and approve the implementation of a management plan developed by the designated Web Vision FCOI Compliance Administrator. Workers with an identified FCOI must comply with the management plan. The management plan will include the following elements at a minimum:
3. Reporting FCOI to EFS Awarding Component (e.g. the TRISH)
At the Beginning of any EFS Event (i.e. new grant) and annually if the funding period is longer than one year in length, FCOI reports (or revised reports as a result of retrospective reviews) will be submitted to the EFS funding source and will include an overview of the grant(s) that include what Workers (including Web Vision employees, sub-contractors, consultants, and advisors) are involved in the EFS project, records indicating their FCOI training and information relating to any potential financial conflicts (or lack of).
If a Conflict is Discovered at any point during the funding period, the designated Web Vision FCOI Compliance Administrator will submit an initial FCOI report to the EFS organization (e.g. TRISH). FCOIs identified during the period of award will be submitted to the EFS within sixty (30) days of identification, including for new Workers joining an ongoing Web Vison EFS project.
Additionally, after the initial notification of a FCOI, the Web Vision FCOI Compliance Administrator will submit a regular status report of the EFS of financial conflict, i.e., whether the financial conflict is still being managed or explains why the financial conflict no longer exists. These FCOI reports will also include a description of any changes to the management plan since the last FCOI report.
4. Training for FCOI
Web Vision Workers that are doing work on EFS projects must undergo training with respect to this Policy and Web Vision FCOI rules and regulations, as follows:
Web Vision will use the NIH web-based training (http://grants.nih.gov/grants/policy/coi/tutorial2011/fcoi.htm) for the FCOI training platform. Workers must save and print the FCOI Certificate as proof of completion.
Note: When the Worker is a sub-contractor, consultant, or advisor and their organization consists of more than one person (i.e. a large organization), WVT MT will select a representative(s) (a company executive), of each company to complete the FCOI training. It will be the responsibility of that person to insure the organization is in compliance with this FCOI Compliance Policy.
5. Sanctions for Violation of Policy
Disclosure of SFI is essential for Web Vision to implement its FCOI Compliance Policy. If a Worker fails to comply with this policy (with regard for instance to the SFI disclosure requirement or implementation of an FCOI management plan), and appears to have biased the EFS research/product development project, the WVT MT will implement a mitigation plan and require that the Worker disclose the FCOI in each public presentation of the results of the research, and to remedy previously published presentations with an FCOI disclosure addendum. In addition, the Worker may be subject to employment/contract discipline including, without limitation, suspension or termination of employment or cancellation of the contract/agreement.
In any case, the EFS agency will be promptly notified.
6. Retention of Records
Records of financial disclosures and any resulting action will be maintained for three (3) years from the date of submission of the final expenditures report.
7. Sub-contractor, Consultant or Advisor Compliance
When working with an external Worker (collective a sub-contractor, consultant, advisor), a written agreement will be put in place to clarify: (a) which organization’s FCOI Compliance Policies are relevant to the organization and will be followed, and, (b) in either case, clarify the timeline for disclosure and reporting. Note: the WVT MT is responsible for monitoring subcontractor’s compliance with the Financial Conflict of Interest regulation, management plans, and for reporting all identified financial conflicts of interest.
8. Public Accessibility
The Web Vision FCOI Compliance Policy is being made accessible on Web Vision Technologies web site (www.WebVisionTechnologies.net).
If a Worker holds financial interests that are determined to be FCOI, as required by this Web Vision FCOI Compliance Policy, these will also be posted on the web site, as follows: