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Financial Conflicts of Interest in PHS/NIH Research (Temporary Policy 1115)

Temporary University Policy 1115

Download a Printable Version of Temporary Policy 1115

Effective Date

February 24, 2026

Last Revision Date

N/A

Responsible Party

Office of Research Compliance, coi@boisestate.edu

Scope and Audience

Personnel meeting the definition of a PHS Investigator.

Additional Authority

42 CFR Part 50 Subpart F Promoting Objectivity in Research

45 CFR Part 94, “Responsible Prospective Contractors”

University Policy 1110 (Conflict of Interest and Conflict of Commitment)

1. Policy Purpose

The purpose of this policy is to promote objectivity in research by establishing standards that provide a reasonable expectation that the design, conduct, and reporting of research performed under PHS/NIH grants or cooperative agreements will be free from bias resulting from Investigator financial conflicts of interest.

The United States Department of Health and Human Services (HHS) developed the regulations at 42 CFR Part 50 Subpart F and 45 CFR Part 94 to promote objectivity in Public Health Service (PHS) funded research for grants, cooperative agreement and research contracts, respectively.

The regulations apply to all National Institutes of Health (NIH) applications and funded grants, cooperative agreements, and research contracts, excluding the Phase 1 Small Business Innovation Research (SBIR) or Small Business Technology Transfer (STTR) applications and/or awards.

2. Policy Statement

When applying for PHS/NIH funding, the University is required to have a written policy in effect that is posted on a publicly accessible website and collect disclosures of “Significant Financial Interests” from those individuals who plan to participate in PHS/NIH-funded research that meet the regulatory definition of “Investigator.” These requirements also work together to preserve the public’s trust that the research supported by the PHS/NIH is conducted without bias and with the highest scientific and ethical standards. 

3. Definitions

3.1 Designated Official (DO)

The individual designated by the University to oversee the financial conflicts of interest process, including solicitation and review of disclosures of significant financial interests, identification of FCOIs per the regulatory criteria provided in 42 CFR 50.604(f), and monitoring staff FCOI training requirements.  The Vice President for Research selects the individual who will serve as the Designated Official (DO).

3.2 Financial Conflict of Interest (FCOI)

A significant financial interest that could directly and significantly affect the design, conduct, or reporting of PHS-funded research. 

3.3 FCOI Signing Official (SO)

The FCOI SO is designated by the University to have the authority to submit FCOI reports to the NIH.

3.4 Financial Interest

Anything of monetary value, whether or not the value is readily ascertainable.

3.5 Institution

Any domestic or foreign, public or private, entity or organization (excluding a federal agency) that is applying for, or that receives, Public Health Service funding.

3.6 Institutional Responsibilities

Specific responsibilities or particular professional activities performed on behalf of the University that directly establish the substantive basis for supervisory assessment of an individual’s University job performance. For faculty, this includes activities such as research, research consultation, outreach, administrative duties, teaching, professional practice, or institutional committee memberships (see University Policy 4000). For non-faculty, this includes the particular duties and responsibilities assigned to one’s position of appointment as expressed in one’s job description. University personnel are expected to meet the specific responsibilities and particular professional activities that constitute their corresponding commitments to their respective schools, colleges, academic units, or administrative units.

3.7 Investigator

The Project Director or Principal Investigator (PD/PI) and any other person, regardless of title or position, who is responsible for the design, conduct, or reporting of research funded by an award or proposed for funding, which may include collaborators or consultants. The University will consider the individual’s role, rather than the title, and the degree of independence with which the individual works when determining who is responsible for the design, conduct, or reporting of the PHS-Funded Research. 

3.8 PHS

The Public Health Service 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 the National Institutes of Health (NIH).

3.9 PHS-Funded Research

Any activity for which research funding is available from a PHS Awarding Component through a grant, cooperative agreement, or contract, whether authorized under the PHS Act or other statutory authority. 

3.10 Research

Research means a systematic investigation, study, or experiment designed to develop or contribute to generalizable knowledge relating broadly to public health, including behavioral and social-sciences research. The term encompasses basic and applied research (e.g., a published article, book, or book chapter) and product development (e.g., a diagnostic test or drug). As used in the regulation, the term includes any such activity for which research funding is available from a PHS Awarding Component through a grant, cooperative agreement, whether authorized under the PHS Act or other statutory authority, such as a research grant, career development award, center grant, individual fellowship award, infrastructure award, institutional training grant, program project or research resources award.

3.11 Senior/Key Personnel

The PD/PI and any other person identified as senior/key personnel by the University in the grant application, progress report, or any other report submitted to the PHS/NIH by the University.

3.12 Significant Financial Interest (SFI) 

A domestic or foreignfinancial 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 appear to be related to the Investigator’sinstitutional responsibilities(e.g., research, consulting, public relations, fundraising, etc.) performed on behalf of the University:

  • Publicly Traded Entity. A significant financial interest 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.  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. 
  • Non-Publicly Traded Entity. A significant financial interest exists if the value of any remuneration received from the entity in the twelve 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 option, or other ownership interest). 
  • Intellectual Property Rights and Interests. A significant financial interest exists upon receipt of income greater than $5,000 received over the preceding months that is related to such rights and interests (e.g., patents, copyrights). Royalties received by the Investigator from the University would be excluded from the definition of Significant Financial Interest if the Investigator is currently employed or otherwise appointed by the University.

Investigators must disclose the occurrence of any reimbursed or sponsored travel (i.e., 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 the Investigator’s institutional responsibilities.  The initial disclosure of reimbursed or sponsored travel should include income received over the previous twelve months. The details of this disclosure will include, at a minimum, the purpose of the trip, the identity of the sponsor/organizer, the destination, and the duration.  

The disclosure requirement does not apply to travel reimbursed or sponsored by the following:

  • A federal, state, or local government agency located in the United States, 
  • A United States Institution of higher education, 
  • An academic teaching hospital, 
  • A medical center, or 
  • A research institute affiliated with a United States Institution of Higher Education. 

The term SFI does notinclude, and therefore, Investigators are not required to disclose, the following types of financial interests: 

  • Salary, royalties, or other remuneration paid by the University to the Investigator if the Investigator is currently employed or otherwise appointed by the University, including intellectual property rights assigned to the University and agreements to share in royalties related to such rights. 
  • 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, a U.S. Institution of higher education, an academic teaching hospital, a medical center, or a research institute affiliated with a U.S.  Institution of higher education. 
  • Income from service on advisory committees or review panels for a federal, state, or local government agency located in the United States, a U.S. Institution of higher education, an academic teaching hospital, a medical center, or a research institute affiliated with a U.S.  Institution of higher education. 

NOTE: Exclusions above do not apply to Foreign Financial Interests. Investigators must disclose all  foreign financial interests (including income from seminars, lectures, or teaching engagements, income from  service on advisory committees or review panels, and reimbursed or sponsored travel) received from any  foreign entity, including foreign Institutions of higher education or a foreign government (which includes  local, provincial, or equivalent governments of another country) when such income meets the threshold for  disclosure (e.g., income in excess of $5,000). 

4. Significant Financial Interest Investigator Disclosure Requirements         

Investigators will disclose their SFIs that are related to their “institutional responsibilities” as defined in the policy.  

The disclosure will not be limited to an Investigator’s research responsibilities or their funded research as this is too narrow in scope and not consistent with the regulations.  

The Investigator SFI disclosures will be retained by the University as part of the record maintenance requirements.  Investigators will disclose their SFIs at the following times:  

  • At the time of application: The Principal Investigator and all other individuals who meet the definition of ‘Investigator’ must disclose their SFIs to the University’ DO. Any new Investigator who, after applying for NIH funding or during the course of the research project, plans to participate in the project must similarly disclose their SFI(s) to the DO promptly and prior to participation in the project. 
  • Annually: Each Investigator participating in research under an NIH award must submit an updated disclosure of SFI at least annually, during the period of the award. The annual disclosure must include any information not disclosed initially to the University pursuant to this Policy or in a subsequent disclosure of SFI (e.g., any FCOI identified on an NIH-funded project directly as an NIH Grantee and/or indirectly through a sub-award) that was transferred from another institution, and must include updated information regarding any previously disclosed SFI (e.g., the updated value of a previously disclosed equity interest). 
  • Ad Hoc Basis – New SFIs During the Award: Each Investigator participating in PHS/NIH-funded research must submit an updated disclosure of SFI within thirty (30) days of discovering or acquiring a new SFI (e.g., through purchase, marriage, or inheritance). Investigators must also submit an updated disclosure of reimbursed or sponsored travel within 30 days of each occurrence.

5. Review of SFI Disclosures by Designated Official

The DO will conduct reviews of any PHS/NIH SFI’s identified in a disclosure.

The SFI disclosures will be reviewed as described below:

  • Prior to the expenditure of PHS/NIH awarded funds.  
  •  A review of each Investigator’s updated SFI disclosure at least annually. 
  •  A review conducted following an Investigator’s ad hoc disclosure of a new SFI. Such disclosures must be submitted within 30 days of the interest being discovered or acquired.

6. Guidelines for Determining ‘Relatedness’ of SFI to PHS/NIH-Funded Research and an FCOI

The DO will determine whether an Investigator’s SFI is related to the research under an NIH award and, if so, whether the SFI is a FCOI. 

6.1 Relatedness Test

An Investigator’s SFI is related to the research when the DO reasonably determines the SFI: 

  • Could be affected by the PHS/NIH-funded research; or 
  • Is in an entity whose financial interest could be affected by the PHS/NIH- funded research. 

The DO may involve the Investigator in determining whether an SFI is related to the NIH-funded research.  

6.2 FCOI Determination

A FCOI exists when the DO reasonably determines that the SFI could directly and significantly affect the design, conduct, or reporting of the PHS/NIH-funded research. ‘Significantly’ means that the financial interest would have a material effect on the research.

7. Management of Significant Financial Interests that Pose an FCOI

If a FCOI exists, the DO will determine what management conditions and/or strategies will be put in place to manage the FCOI. Examples of conditions that might be imposed to manage an FCOI include, but are not limited to:  

  • Public disclosure of financial conflicts of interest (e.g., when presenting or publishing the research, to research personnel working on the study, to the University’s Institutional Review Board, Institutional Animal Care and Use Committee, Data Safety and Monitoring Board, etc.); 
  • For research projects involving human subjects research, disclosure of financial conflicts of interest directly to human participants in the informed consent document; 
  • Appointment of an independent monitor capable of taking measures to protect the design, conduct, and reporting of the research against bias resulting from the FCOI; 
  • Modification of the research plan; 
  • Change of personnel or personnel responsibilities, or disqualification of personnel from participation in all or a portion of the research; 
  • Reduction or elimination of the financial interest (e.g., sale of an equity interest); 
  • Severance of relationships that create financial conflicts. 

If the DO determines that a conflict exists, it will communicate its determination and the means developed for managing the FCOI in writing to the individual. 

No expenditures on an NIH award will be permitted until the Investigator has complied with the Disclosure requirements of this Policy and has agreed, in writing, to comply with any plans determined by the DO necessary to manage the FCOI. The FCOI Signing Official will submit the FCOI report to NIH via the eRA Commons FCOI Module.

8. Monitoring Investigator Compliance

The University will monitor Investigator compliance with the management plan for the duration of the NIH award or until the FCOI no longer exists. Monitoring of public disclosure requirements will include reviewing publications and presentations to confirm that the Investigator disclosed the FCOI in such communications. To facilitate additional monitoring, Investigators will be required to disclose the FCOI in writing to research personnel in the study and send a copy of the communication to the DO which will serve as documentation for compliance with the management plan.

9. Public Accessibility of the FCOI Policy and FCOI Information Held by Senior/Key Personnel

9.1 FCOI Policy

A copy of the FCOI policy is posted on the University’s public policy website per the NIH requirements.

9.2 Identified FCOIs held by Senior/Key Personnel

Prior to the expenditure of any funds under a PHS award, the University will ensure public accessibility by providing a written response to any requestor within five business days of a request for information concerning any SFI disclosed that meets the following three criteria:  

  • The SFI was disclosed and is still held by the senior/key personnel (PD/PI and any other person identified as senior/key personnel by the University in the award application, progress report, or any other report submitted to the PHS);
  • The University has determined that the SFI is related to the research funded through an award; and
  • The University has determined that the SFI is an FCOI. 
  • The information made available via the public website or in a written response will include, at a minimum: 
  • The Investigator’s name; 
  • The Investigator’s title and role with respect to the research project; 
  • The name of the entity in which the Significant Financial Interest is held; 
  • The nature of the Significant Financial Interest; and 
  • The approximate dollar value of the Significant Financial Interest in the following ranges:
    • $0-$4,999; $5,000- $9,999; $10,000-$19,999;
    • amounts between $20,000-$100,000 by increments of $20,000;
    • amounts above $100,000 by increments of $50,000;
    • or a statement that the interest is one whose value cannot be readily determined through reference to public prices or other reasonable measures of fair market value. 

The written response will note that the information provided is current as of the date of the correspondence and is subject to updates on at least an annual basis and within 60 days of the University’s identification of a new FCOI which should be requested subsequently by the requestor.  

If the University uses a publicly accessible website to meet this requirement, the information posted will be updated at least annually and within 60 days of:  

  • Receiving or identifying an additional SFI of Senior/Key personnel related to the NIH-funded research that was not previously disclosed, or  
  • A new SFI being disclosed by Senior/Key personnel joining the project and determined by the DO to be related to the research and an FCOI.  

Information on SFIs subject to the public accessibility requirement will remain available for at least three years from the most recent update.

10. Reporting of Identified Financial Conflicts of Interest 

10.1 Initial or Original FCOI Reports

  • The University will assign an institutional official to serve as the FCOI Signing Official (SO) within the eRA Commons FCOI Module. The FCOI SO has the authority to submit FCOI reports to the NIH. FCOI reports are submitted to the NIH only when a grant or cooperative agreement is active and an FCOI is identified.
  • Prior to the Expenditure of Funds: When an FCOI is identified upon the issuance of a new NIH award, the FCOI SO will submit a NIH “2011 FCOI” Original report prior to the expenditure of any funds under an NIH award. The Original FCOI report will include the information required in the regulation at 42 CFR Part  50.605(b)(3). 
  • Within 60 days of Identifying a new FCOI During Award Period: When an FCOI is identified during the period of an NIH-funded award (e.g., a new SFI is identified for an Investigator, or upon the participation of a new Investigator), The University will provide to NIH within 60 days of identifying the FCOI, an Original FCOI report regarding the FCOI.

10.2 Annual FCOI Reports

While the award is ongoing (including any extensions with or without funds), the University will provide NIH with an annual FCOI report that addresses the status of the previously reported FCOI (i.e., whether the FCOI is still being managed or if it no longer exists) and any changes in the management plan, if applicable. 

The Annual FCOI report will be submitted at the same time as when the Research Performance Progress Report or multi-year progress report is due and at the time of grant extension, if applicable. The NIH will send an annual report email notification to the University when an annual report is due. 

Annual FCOI reports are not submitted as part of grant closeout.  

10.3 Revision (or Mitigation) FCOI Reports

Following the completion of a retrospective review, the University will provide NIH with a Revision if new information is discovered or a Mitigation Report if bias is found.  

11. Training Requirements  

Each Investigator will be informed about this policy and trained on the Investigator’s responsibility to disclose foreign and domestic SFIs per this policy and the FCOI regulation at 42 CFR Part 50 Subpart F. FCOI training will occur prior to an Investigator engaging in PHS/NIH-funded research, at least every four years, and immediately when any of the following circumstances apply: 

  • The University revises this Policy, or procedures related to this Policy, in any manner that affects the requirements of Investigators; 
  • An Investigator is new to the University research under an NIH award (training is to be completed prior to his/her participation in the research); or 
  • The University finds that an Investigator is not in compliance with this Policy or a management plan issued under this Policy (training is to be completed within 30 days in the manner specified by the DO). 

To fulfill the FCOI training requirement, The University requires its Investigators to complete the FCOI training module via the CITI Program Platform.   

12. Failure to Comply

Whenever the University identifies an SFI that was not disclosed, identified, reviewed or managed in a timely manner, the DO will within 60 days: review the SFI, determine whether the SFI is related to research; determine whether an FCOI exists, and, if so, implement, on at least an interim basis, a management plan that shall specify the actions that have been, and will be, taken to manage such FCOI going forward. The University will also submit an FCOI report to the PHS/NIH via the eRA Commons FCOI Module. 

In addition, whenever an FCOI is not identified or managed in a timely manner, including:

  • Failure by the Investigator to disclose a significant financial interest that is determined by the University to constitute a FCOI; 
  • Failure by the University to review or manage such an FCOI; 
  • Failure by the Investigator to comply with a management plan; 

The University will, within 120 days of determining non-compliance:  

  • Complete a retrospective review of the Investigator’s activities and the PHS/NIH- funded research project to determine whether any NIH-funded research, or portion thereof, conducted during the period of the noncompliance was biased in the design, conduct, or reporting of research; 
  • Document the retrospective review consistent with the regulation at 42 CFR 50.605(a)(3)(ii)(B). 

If bias is found, the University shall notify NIH promptly and submit a mitigation report per the regulation at 42 CFR 50.605(a)(3)(iii) to NIH via the eRA Commons FCOI Module that shall address:

  • Impact of the bias on the research project, and 
  • The University’ plan of action or actions taken to eliminate or mitigate the effect of the bias. 

Thereafter, the University will submit FCOI reports annually to NIH in accordance with the NIH guidance as provided in the summary chart above. Depending on the nature of the FCOI, the University may determine that additional interim measures are necessary with regard to the Investigator’s participation in the research project between the date that the FCOI is identified and the completion of the University’ independent retrospective review. 

If bias is not found, no further action will be taken unless new information is discovered that needs to be reported to the NIH. If applicable, update existing FCOI report to specify the actions that have been, and will be, taken to manage the FCOI going forward or update previously submitted report information (e.g., increase in value of the SFI or add any newly identified SFIs) following the completion of the retrospective review. 

13. Clinical Research Requirements 

If the Department of Health and Human Services determines that one of its funded clinical research projects, whose  purpose is to evaluate the safety or effectiveness of a drug, medical device, or treatment, has been designed, conducted,  or reported by an Investigator with an FCOI that was not managed or reported by the University the University shall require the Investigator involved to disclose the Financial Conflict of  Interest in each public presentation of the results of the research and to request an addendum to previously published  presentations. 

14. Subrecipient Requirements 

A subrecipient relationship is established when federal funds flow down from or through the University to another individual or entity, and the subrecipient will be conducting a substantive portion of a PHS-funded research project and is accountable to the University for programmatic outcomes and compliance matters.  Subrecipients are subject to the terms and conditions of the subaward agreement, including terms that establish whether the Financial Conflict of Interest policy of the pass-through entity or that of the subrecipient will apply to the subrecipient’s Investigators. The University will take reasonable steps to ensure that any subrecipient Investigator is in compliance with the federal FCOI regulation at 42 CFR Part 50 Subpart F. 

The University will incorporate, as part of a written agreement with the subrecipient, terms that establish whether the University’ s FCOI Policy or that of the subrecipient’s institution will apply to the subrecipient Investigator(s). 

14.1 If the subrecipient’s FCOI policy applies

The subrecipient institution will certify as part of the agreement with the University that its policy is in compliance with the federal FCOI regulation. The agreement shall specify the time period for the subrecipient to report all identified FCOIs to the University (e.g., within 55 days of identification to allow the University to report within 60 days) to enable the University to provide timely FCOI reports to the PHS/NIH as required by the regulation. The University assigned FCOI SO will submit the FCOI report (subrecipient report) to the NIH via the eRA Commons FCOI Module. 

14.2 If the subrecipient cannot provide certification

The agreement shall state that the subrecipient Investigator is subject to the University’ FCOI Policy for disclosing SFI(s) that are directly related to the subrecipient’s work for the University. The University will require the submission of all Investigator disclosures of SFIs to the University. The agreement will include sufficient time period(s) to enable the University to comply timely with its review, management, and reporting obligations under the regulation. When an FCOI is identified, the University will develop a management plan, monitor subrecipient Investigator compliance with the plan, and submit an FCOI report (subrecipient report) to the NIH through the eRA Commons FCOI Module. 

15. Maintenance of Records  

The University will keep all records of all Investigator disclosures of financial interests and the University’s review of, or response to, such disclosures (whether or not a disclosure resulted in the determination of an FCOI), and all actions under this policy or retrospective review, if applicable. Records of financial disclosures and any resulting action will be maintained for at least three years from the date of submission of the final expenditures report or, where applicable, from other dates specified in 2 CFR 200.234 for different situations. The university will retain records for each competitive segment as provided in the regulation. 

In addition, the University will make information available, promptly upon request, to the HHS relating to any Investigator disclosure of financial interests and the University’s review of, and response to such disclosure whether or not the disclosure resulted in the University’s determination of an FCOI per the regulation 42 CFR 50.606(b). 

16. Enforcement Actions When an Investigator Fails to Comply with This Policy 

Compliance with this policy is a condition of employment and/or participation for all applicable Investigators.  Investigators who fail to comply with this policy are subject to discipline, including letters of reprimand, restriction on the use of funds, termination of employment, or disqualification from further participation in any PHS/NIH-funded research, as deemed appropriate.

Office of Research Compliance COI webpage

Last Review Date

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Revision History

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