Financial Conflict of Interest Procedure

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Purpose

To promote the objectivity in research required by the Public Health Services (PHS), this procedure establishes required institutional management, Investigator responsibilities and processes, and requirements for PHS applications and funding.

Scope

Intermountain Health Care, Inc.

Definitions

Institutional Official - Institutional official(s) assigned by Intermountain to solicit and review disclosures of Significant Financial Interests from Investigators who are planning to participate in, or are participating in, PHS-funded research. The Official(s) review disclosures and determines whether any Significant Financial Interest is related to PHS-funded research and if a Financial Conflict of Interest exists by making a reasonable determination that the Significant Financial Interest could be affected by the PHS-funded research, or is in an entity whose Financial Interest could be affected by the research.
Financial Conflict of Interest (FCOI) - A Significant Financial Interest that could directly and significantly affect the design, conduct, or reporting of PHS-funded research.
Financial Interest - Anything of monetary value, whether or not the value is readily ascertainable.
Significant Financial Interest - Exists and is related to the research when the Significant Financial Interest could be affected by the PHS funded research, or is in an entity whose Financial Interest could be affected by the research. Further, a Significant Financial Interest means: (1) A Financial Interest consisting of one or more of the following interests of the Investigator (and those of the Investigator’s spouse, dependent children, or any combination) that reasonably appears to be related to the Investigator’s institutional responsibilities: a. 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 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 includes any stock, stock option, or other ownership interest, as determined through reference to public prices or other reasonable measures of fair market value; or b. With regard to any non-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, when aggregated, exceeds $5,000, or when the Investigator (or the Investigator’s spouse or dependent children, or any combination) holds any equity interest (e.g., stock, stock option, or other ownership interest); or c. Intellectual property rights and interests (e.g., patents, copyrights), upon receipt of income related to such rights and interests. (2) 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, a medical center, or a research institute that is affiliated with an Institution of higher education. Pursuant to Intermountain’s Conflict of Interest 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 PHS-funded research. (3) The term “Significant Financial Interest” does not include the following types of Financial Interests: salary, 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 signed to the Institution and agreements to share in royalties related to such rights; any ownership interest in the Institution held by the Investigator, etc .
Investigator - 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.
Senior Key Research Personnel - The Principal Investigator and any other person identified as senior/key personnel by Intermountain in the grant application, progress report, or any other report submitted to PHS by Intermountain.
Public Health Service (PHS) - A service of the U.S. Department of Health and Human Services, and includes any components of the PHS to which the authority involved may be delegated, including the National Institutes of Health (NIH).
Subrecipient - A Subrecipient relationship is established when federal funds flow down from or through an awardee Institution to another individual or entity and the Subrecipient will be conducting a substantive portion of the PHS-funded research project and is accountable to the awardee institution for programmatic outcomes and compliance matters.

Procedure

Exceptions

Exceptions to this procedure must be approved by the Vice President of Research.

Primary Sources

Secondary Materials