Financial Conflict of Interest (FCOI) Policy

RetiVue LLC thru its research efforts strives to ensure public trust and meet all stated scientific research, and ethical goals of its National Institutes of Health grant programs. We strive for maintaining objective research thru the efforts of its own employees, its subaward grantees, sub-contractors, and vendor relationships. RetiVue LLC has developed the policy below to ensure it both identifies and mitigates any potential financial conflict of interests in accordance with the requirements of the Public Health Service (PHS) and the Office of the Secretary of the U.S. Department of Health and Human Services (HHS). This policy is available publicly at: https://www.retivue.com/fcoi

RetiVue LLC requires all investigators, employees, subaward grantees, and vendors that are affiliated with our NIH and affiliated grant or contract work be in compliance with 1) 42 CFR Part 50 subpart F for PHS grants and 2) 45 CFR Part 94 for contracts. While this policy is developed to specifically meet NIH FCOI requirements, RetiVue will follow this policy for any additional federal grant or contract work it undertakes, amended according to the specific requirements of the granting agencies.

Key policy definitions apply to principal investigators, subaward grantees, employees conducting research on behalf of the PHS grant, and any collaborators that are affiliated with RetiVue.

Investigator

An Investigator is any person who is responsible for the design, conduct or reporting of research funded by PHS, inclusive of sub-awardees and collaborators.

Training Requirement

RetiVue LLC requires all investigators, employees, sub-awardees, and vendors to ensure completion of training modules regarding Financial Conflict of Interest (FCOI). If any conflicts of interest are known or discovered, they are required to be disclosed. Recertification of training must be completed at a minimum of every 4 years or as as required based on granting agency or project role. The NIH provides via their website information regarding financial conflict of interest in addition to appropriate training modules for purposes of certification: http://grants.nih.gov/grants/policy/coi/tutorial2011/fcoi.htm

Significant Financial Interest (SFI)

Significant Financial Interest is defined by NIH policy regulations as:

A financial interest consisting of one or more of the following interests of the investigator (and those of the investigator’s spouse and dependent children) that reasonably appears to be related to the investigators institutional responsibilities:
1. With regard to any publicly traded entity a significant financial interest exists if the value of any remuneration received from the entity in the 12 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. For the purposes of this definition, remuneration includes salary and any payment for services not otherwise identified as salary (e.g. consulting fees, honoraria, paid authorship); equity interest in stock, stock options or other ownership interest, as determined through reference to public prices and other reasonable measures of fair market value
2. With regard to any non-publicly traded entity, a significant financial interest exists if the value of any remunerations from the entity in the 12 months preceding the disclosure, when aggregated, exceeds $5,000, or when the Investigator (or the Investigator’s spouse or dependent children) holds any equity interests (e.g. stock, stock options, or other ownership interest) or
3. Intellectual property rights and interests (e.g. patents, copyrights), upon receipt of income related to such rights and interests.
Investigators also must disclose the occurrence of any reimbursed or sponsored travel (i.e., that which is paid on behalf of the investigator and not reimbursed to the investigator so that the exact monetary value may not be readily available) related to their institutional responsibilities; provided, however, that 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 as defined at 20 U.S.C. 1001(a), an academic teaching hospital, medical center, or research institute that is affiliated with an institution of higher education. The institution’s FCOI policy will specify the details of this disclosure, which will include, at a minimum, the purpose of the trip, the identity of the sponsor/organizer, the destination, and the duration. In accordance with the institution’s FCOI policy, the institutional official(s) will determine if further information is needed, including a determination or disclosure of monetary value, in order to determine whether the travel constitutes a FCOI with the PHS-funded research.
The term significant financial interest does not include the following types of financial interests: salaries, royalties or other remuneration paid by the institution to the Investigator if the investigator is currently employed or otherwise appointed by the institution, including intellectual property rights assigned to the institution and agreements to share in royalties related to such rights; any ownership interest in the Institution held by the investigator, if the institution is a commercial or for profit organization; income from investment vehicles, such as mutual funds and retirements 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 at 20 U.S.C. 1001(a), an academic teaching hospital, a medical center, research institute that is affiliated with an Institution of higher education; or income from service on advisory committees or review panels for a federal, state or local government agency 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.

Financial Conflict of Interest

A Financial Conflict of Interest (FCOI) exists when RetiVue LLC reasonably determines that a Significant Financial Interest could directly and significantly affect the design, conduct or reporting of NIH sponsored research.

Management of a Financial Conflict of Interest

Management of a Financial Conflict of Interest is defined as RetiVue LLC taking action to address a financial conflict of interest (FCOI), which can include but it not limited to reducing or eliminating the FCOI, to ensure, to the extent possible, that the design, conduct, and reporting of research will be free from bias.

PHS Awarding Component

The PHS awarding component is any sub-agency of the Public Health Service or Department of Health and Human Services.

Disclosures/Reporting Process

RetiVue’s designated official(s) reviews all required disclosure documents submitted reporting personnel and evaluate whether they contain any potential FCOI. All disclosure documents will be maintained by RetiVue LLC within a designated SFI binder. If a FCOI is identified these findings will be included within the FCOI report filed through the eRA Commons FCOI module prior to expending any funds. If any interests are identified as conflicting subsequent to the initial report they must be reported to RetiVue within 30 days and will then be reported to the PHS awarding component within 60 days. Each investigator must submit an updated disclosure of an SFI not less than annually. If a PHS-funded project is conducted by an investigator or SO with a conflict that was not disclosed or managed, that is subsequently discovered, RetiVue is required to disclose the conflict in each public presentation related to the results of the research.

Records Management

The records of all financial disclosures and all actions taken by RetiVue LLC will be maintained for at least three years from the date of submission of the final expenditures report.

Research

PHS research is any project governed by PHS regulation, but excluding applications for Phase I support under the Small Business Innovation Research (SBIR) and Small Business Technology Transfer (STTR) programs.

Compliance and Penalties for Non-Performance

If an investigator or any personnel required to complete FCOI submission fails to comply with this stated FCOI policy, within 120 days, RetiVue shall complete a retrospective review of the investigator or personnel’s activities to determine if there is evidence of bias. If bias is found, RetiVue shall submit a mitigation report to the NIH, in accordance with 42 CFR 50.605(b)(3), that shall address the impact of the bias on the research project and the actions it has taken to mitigate the bias. RetiVue will work with the personnel to establish an FCOI management plan to mitigate the identified FCOI and rectify the determined bias. RetiVue LLC is required to mandate the investigator or other project personnel disclose the FCOI in each public presentation of research results if it was not reported initially. In extreme cases of bias, the investigator or project personnel may lose the right to work on the project or receive future NIH funding.