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.
Intermountain Health Care, Inc.
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.
Federal regulations promote objectivity in research by establishing standards that provide a reasonable expectation that the design, conduct, and reporting of research funded under PHS is free from bias resulting from an Investigator with a Financial Conflict of Interest. This procedure is updated and enforced to comply with regulatory requirements and is available via a publicly accessible Web site.
Intermountain informs impacted Investigator(s) of their conflict of interest policy and procedures, the Investigator’s responsibility to disclose Significant Financial Interests, applicable conflict or interest regulations, and requires each Investigator to complete training regarding these matters prior to engaging in research related to any PHS-funded grant.
Intermountain designates Institutional Official(s) to solicit and review Significant Financial Interest disclosures as required.
Intermountain provides guidelines to designated Institutional Official(s) to determine whether an Investigator’s Significant Financial Interest is related to PHS-funded research and, if so related, whether the Significant Financial Interest is a FCOI.
Intermountain's Institutional Official(s) will reasonably determine if the Significant Financial Interest could be affected by the PHS-funded research or is in an entity whose Financial Interest could be affected by research. The Investigator may be involved in the determination. A FCOI exists when Intermountain, through its Institutional Official(s), reasonably determines that the Significant Financial Interest could directly and significantly affect the design, conduct, or reporting of the PHS-funded research.
Intermountain takes action to manage FCOI, including any Subrecipient Investigator's FCOI. Management of an identified FCOI requires development and implementation of a management plan and, if necessary, a retrospective review and mitigation report.
Intermountain provides initial and ongoing FCOI reports to the PHS as required and maintains records relating to all Investigator Significant Financial Interest disclosures and Intermountain’s review of, and response to, such disclosures and retrospective reviews (whether or not a disclosure resulted in Intermountain’s determination of a FCOI) for at least three years from the date that final expenditure report is submitted to PHS.
Intermountain establishes adequate enforcement mechanisms and provides for sanctions and administrative actions to ensure Investigator compliance.
Intermountain certifies In each application for PHS funding that Intermountain:
Has an up-to-date, written, and enforced administrative process to identify and manage FCOI for which funding is sought or received by PHS
Promotes and enforces Investigator compliance with requirements including those pertaining to Significant Financial Interest disclosures
Manages FCOI and provides initial and ongoing FCOI reports to the PHS awarding component
Agrees to make information available, promptly upon request, to the PHS relating to any Investigator Significant Financial Interest disclosures and Intermountain’s review of, and response to such disclosure, whether or not the disclosure resulted in Intermountain’s determination of a Financial Conflict of Interest
Fully complies with the requirements of the 42 CFR Part 50, Subpart F and 45 CFR Part 94
For Subrecipients (e.g., subcontractors or consortium members), Intermountain takes reasonable steps to ensure that any Subrecipient Investigator complies with FCOI regulations by:
Incorporating as part of a written agreement or subcontract terms that establish whether Intermountain policy or that of the Subrecipient will apply to Subrecipient’s Investigators:
If Subrecipient Investigators must comply with the Subrecipient’s Financial Conflict of Interest policy, the Subrecipient must certify as part of the agreement or subcontract referenced above that its policy complies with required regulation. If the Subrecipient cannot provide such certification, that agreement or subcontract must state that Subrecipient Investigators are subject to Intermountain's policy for disclosing Significant Financial Interests that are directly related to the Subrecipient’s work for Intermountain.
If the Subrecipient’s Investigators must comply with the Subrecipient’s Financial Conflict of Interest policy, the agreement or subcontract referenced above must specify time periods(s) for the Subrecipient to report all identified Financial Conflicts of Interest to Intermountain. Such time period(s) must be sufficient to enable Intermountain to provide timely FCOI reports, as necessary, to the PHS as required.
Alternatively, if the Subrecipient’s Investigators must comply with Intermountain's policy, the agreement referenced above shall specify time period(s) for the Subrecipient to submit all Investigator disclosures of Significant Financial Interests to Intermountain. Such time period(s) will be sufficient to enable Intermountain to comply with its review, management, and reporting obligations.
Providing FCOI reports to the PHS awarding component regarding all Financial Conflicts of Interest of all Subrecipient Investigators prior to the expenditure of funds and within 60 days of any subsequently identified FCOI.
Investigator and Senior Key Research Personnel are required to:
Disclose to Intermountain’s Institutional Official(s) the Investigator’s Significant Financial Interests (and those of the Investigator’s spouse and dependent children) no later than the time of application for PHS-funded research.
Submit an updated Federal Financial Conflict of Interest Disclosure form at least annually, or in accordance with the specific time period prescribed by Intermountain during the period of the award. Annual disclosures must include any information that was not disclosed initially to Intermountain, or in subsequent disclosures of Significant Financial Interest (e.g., any FCOI identified on a PHS-funded project), and must include updated information regarding any previously disclosed Significant Financial Interest (e.g., updated value of previously disclosed equity interest).
Submit an updated Federal Financial Conflict of Interest Disclosure form within 30 days of discovering or acquiring (e.g., through purchase, marriage or inheritance) a new Significant Financial Interest.
Complete training regarding Significan Financial Interest prior to engaging in research related to any PHS-funded grant at least every four years, and immediately when:
Intermountain revises its conflict of interest policies or procedures in any manner that affects the requirements of Investigators
An Investigator is new to Intermountain
Intermountain finds that an Investigator is not in compliance with this procedure or management plan.
Exceptions to this procedure must be approved by the Vice President of Research.
- Title 42 Code of Federal Regulation (CFR) Part 50 Subpart F for grants and cooperative agreements
- Title 45 CFR Part 94 for research contracts