Dynocardia - Financial Conflict of Interest (FCOI) Policy
Scope:
This policy applies to all of Dynocardia’s employees and contractors who are responsible for the design, conduct or reporting of research on federally funded grants and cooperative agreements.
Additionally, this policy applies to Investigators participating in federal research, as defined by the PHS Regulation, including subgrantee/collaborating Investigators, but excluding applications for Phase I support under the SBIR and Small Business Technology Transfer (STTR) programs.
A. Institution: means Dynocardia, Inc.
B. PHS: Public Health Service (PHS) of the U.S. Department of Health and Human Services, and any components of the PHS to which the authority involved may be delegated, including, among others, the National Institutes of Health (NIH). A listing of the PHS agencies and their offices may be located on the U.S. Department of Health and Human Services Organizational Chart.
C. PHS Regulations: U.S. 42 CFR Part 50, Subpart F and 45 CFR Part 94
D. PHS Funded Research: is any project governed by PHS regulation
E. PHS Awarding Component: is any sub-agency of the Public Health Service or Department of Health and Human Services.
F. Covered Individual: Any of the Institution’s employee or contractor who is responsible for the design, conduct or reporting of a PHS Funded Research or proposed for such project, including any project director, principal investigator and any other key personnel designated as such in a PHS Research Grant application or contract.
G. Covered Individual Responsibilities: A Covered Individual’s professional responsibilities performed behalf of the Institution to undertake PHS Funded Research.
H. Immediate Family: A Covered Individual’s spouse or domestic partner and dependent children.
I. Equity Interest: Any stock, stock option, or other ownership interest, as determined through reference to public prices or other reasonable measures of fair market value.
J. Remuneration: (i) salary and any payment for services including consulting fees and honoraria; (ii) any Equity Interest; and (iii) travel reimbursement related to the Covered Individual Responsibilities.
K. Financial Conflict of Interest (“FCOI”): A Significant Financial Interest that could directly and significantly affect the design, conduct or reporting of PHS-Research.
L. Financial Interest: Any interest of monetary value, whether or not the value is readily ascertainable.
M. Significant Financial Interest (SFI):
The SFI is defined by the PHS Regulation as a Financial Interest consisting of one or more of the following interests of the Covered Individual (and those of the Immediate Family) that reasonably appears to be related to the Covered Individual Responsibilities:
With regard to any publicly traded entity a SFI exists if the value of any Remuneration received from the 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.
With regard to any non-publicly traded entity, a SFI exists if the value of any remunerations from the entity in the twelve months preceding the disclosure, when aggregated, exceeds $5,000, or when the Covered Individual (or the Immediate Family) holds any equity interests; or
Intellectual property rights and interests (e.g. patents, copyrights), upon receipt of income related to such rights and interests.
The term significant financial interest does not apply to Non-Significant Financial Interests (“Non-SFI”), which include the following types of financial interests:
Salary or other remuneration from the Institution;
Any ownership interests in the Institution;
Income from investment vehicles, such as mutual funds and retirement accounts, as long as the Covered Individual does not directly control the investment decisions made in such 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, or a research institute that is affiliated with an institution of higher education.
Reimbursed or sponsored travel expenses 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, or a research institute that is affiliated with an institution of higher education.