1. Purpose
This procedure establishes a Financial Conflict of Interest (FCOI) policy for the company, across all Departmental or Divisional lines. This procedure is written to ensure compliance with the 2011 FCOI regulation, promoting objectivity in research (42 CFR Part 50 Subpart F) and supersedes any other similar procedures in effect at the date of implementation.
2. Rationale
The 2011 FCOI regulation (42 CFR Part 50 Subpart F) promotes objectivity in research by establishing standards that provide a reasonable expectation that the design, conduct, and reporting of research funded under National Institutes of Health (NIH) grants or cooperative agreements will be free from bias resulting from Investigator FCOIs. To be eligible for NIH funding, Raydiant must maintain and enforce an FCOI policy that meets or exceeds the regulatory requirements.
3. References
OP2384 FC0I Disclosure Form
4. Definitions
Financial Conflict Of Interest (Fcoi)
means a Significant Financial Interest that could directly and
significantly affect the design, conduct, or reporting of the Public Health Service funded research.
Significant Financial Interest (Sfi)
means
A)
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 Investigator’s company responsibilities:
- With regard to any publicly traded entity, an SFI 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. Remuneration includes salary and any payment for services not otherwise identified as salary (e.g., consulting fees, honoraria, paid authorship); equity interest includes any stock, stock option, or other ownership interest, as determined through reference to public prices or other reasonable measures of fair market value.
- With regard to any non-publicly traded entity, an SFI exists if the value of any remuneration
received 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 interest (e.g., stock, stock options, or other ownership interest); or
- Intellectual property rights and interests (e.g., patents, copyrights), upon receipt of income
related to such rights and interests in excess of $5,000.
B)
Investigators also must disclose the occurrence of any reimbursed or sponsored travel in
excess of $5,000 related to their company 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 located in the United States, an United States institution of higher education, an academic teaching hospital, a medical center, or a research institute that is affiliated with an United States institution of higher education. Note: Reimbursed or sponsored travel from a foreign government, which includes local, provincial, or equivalent governments of another country or foreign institutions of higher education must be disclosed when such income is more than $5,000. The details of the disclosure will include, at minimum, the purpose of the trip, the identity of the sponsor/organizer, the destination, and the duration.
C)
The term SFI does not include the following types of financial interests: salary, royalties, or other
remuneration paid by the Institution (i.e., Raydiant Oximetry) to the Investigator if the Investigator is currently employed or otherwise appointed by the Institution, including intellectual property (IP) rights assigned to the Institution and agreements to share in royalties related to such rights; any 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 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 located in the United States, an United States institution of higher education, an academic teaching hospital, a medical center, or a research institute that is affiliated with a United States institution of higher education; or income from any service on advisory committees or review panels for a Federal, state, or local government agency located in the United States, an United States institution of higher education, an academic teaching hospital, a medical center, or a research institute that is affiliated with an United States institution of higher education. Note: Income from seminars, lectures, or teaching engagements and from service on advisory committees or review panels received from a foreign government, which includes local, provincial, or equivalent governments of another country or foreign institutions of higher education must be disclosed when such income meets the threshold for disclosure.
Investigator
means 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 Public Health Service, or proposed for such funding, which may include collaborators or consultants. The Institution will consider the role, rather than the title, of those involved in the research and the degree of independence with which those individuals work in making the determination of who meets the definition of “Investigator.”
Institution
means any domestic or foreign, public or private entity or organization (excluding
a federal agency) that is applying for, or that receives, PHS research funding.
5. Scope
This procedure is applicable to: 1. All Public Health Service (PHS) (e.g., NIH) grants and cooperative agreements, excluding Phase I Small Business Innovative Research (SBIR) applications and awards 2. Each Investigator, as defined by the regulation, who is planning to participate in or is participating in Public Health Service (PHS) funded research.
6. Training Requirements
All Investigators who plan to participate in or are participating in PHS-funded research must be informed of this FCOI policy, the Federal regulation 42 CFR Part 50 Subpart F, and the responsibility to disclose FCOIs per this policy. Investigators must be trained on the above and this FCOI procedure:
- Prior to engaging in PHS-funded research.
- Every four years, thereafter.
- Immediately, if:
- This FCOI policy is revised.
- Investigator is new to the company.
- Investigator does not comply with the FCOI policy or management plan.
Training constitutes Investigators certifying they have read and reviewed:
- OP2383 Financial Conflict of Interest Procedure
- NIH’s “FCOI Training” on Regulation 42 CFR Part 50 Subpart F at FCOI Training | grants.nih.gov.
The FCOI Policy has been implemented in the following ways:
- Each Investigator has been provided a written copy;
- The FCOI Policy has been added to the company website.
7. Disclosure, Review, Monitoring Requirements
Each Investigator has a responsibility to disclose SFIs (and those of the Investigator’s spouse and dependent children) related to the Investigator’s company responsibilities that meet or exceed the definition of SFI as provided in this policy using the company’s Significant Financial Interest Form.
- No later than at the time of application for PHS-funded research
- At least annually during the period of the award
- Within 30 days of discovering or acquiring a new SFI
Raydiant’s Chief Executive Officer (CEO), as the company’s designated institutional official, will solicit and review disclosures of SFIs of the Investigator (and those of the Investigator’s spouse and dependent children) related to the Investigator’s company responsibilities for determination of FCOI. An SFI is related to PHS-funded research if the CEO reasonabl