Purpose
The purpose of these procedures is to establish the process for disclosing outside business interests of any researcher conducting research under the auspices of Utah State University (USU) including researchers involved in the design, conduct, or reporting of human subjects research or an institutional financial interest that is related to human subjects research.
Research Conflicts of Interest (COI) may arise because of the intellectual property involved in research discoveries or industry-academic partnerships, from financial incentives offered to researchers, or due to particular role relationships within the governance structure of organizations or institutions. For researchers, financial or other incentives may impact the collection, analysis and interpretation of data, scientific objectivity and integrity, and ultimately, the public trust in the research enterprise. In addition, a researcher may unwittingly exert coercion or undue influence on prospective participants to participate in research.
Related Policies and Procedures
42 CFR 50 Subpart F PHS Regulation
Association for the Accreditation of Human Research Protection Programs, Standard I.6.A
Department of Energy Interim Conflict of Interest Policy
USU Insitutional Review Board Standard Operating Procedures
USU Policy #545: Individual Conflicts of Interest
USU Policy #403: Professional Responsability, Standards of Conduct
USU Policy #407: Academic Due Process: Sanctions and Hearing Procedures
USU Policy #584: Human Participant in Research
USU Policy #587: Intellectual Property
USU Policy #517: Investment Policies
Definitions
Conflict of Commitment (COC) - a situation where an individual engages in external activities, either paid or unpaid, that interferes with their primary obligation and commitment to USU.
Conflict of Interest (COI) – for this procedure, a conflict of interest is a situation where a USU Researcher’s financial, professional, or other personal considerations or interests may directly or indirectly affect their professional judgment in exercising any professional duty or responsibility to USU, including the design, conduct, and/or reporting of research. (See Financial Conflict of Interest and Conflict of Commitment)
Externally Sponsored or Reimbursed Travel – All travel costs sponsored or reimbursed by a U.S. or foreign organization (either fully or partially), excluding the following: USU, U.S. federal/state/local government agencies, U.S. institutions of higher education, U.S. research institutes associated with institutions of higher education, and U.S. academic teaching hospitals and medical centers. Travel costs include transportation costs, lodging, conference registration, meals/food, and per diem.
Financial Conflict of Interest (FCOI) – A Significant Financial Interest held by an Investigator (or the Investigator’s spouse or dependent children) that could directly and significantly affect decision making in the design, conduct, or reporting of research performed on behalf of USU.
Foreign Affiliation – For the purposes of this procedure, this means any positions or appointments with foreign entities or governments. Includes titled academic, professional, or institutional appointments whether or not renumeration is received, and whether full-time, part-time, or voluntary (including adjunct, visiting, or honorary).
Foreign Talent Program – Based on the National Science Foundation definition, a foreign talent program involves a foreign entity that compensates an individual affiliated with USU in exchange for an agreement to transfer knowledge, expertise, or other intellectual assets to the foreign entity.
Immediate family – For the purposes of this procedure, this means spouse/domestic partner and/or dependent children
Malign Foreign Talent Program (MFTP) – For the purpose of this procedure, a MFTP is a Foreign Talent program that is sponsored by a country of concern, or an academic institution or foreign talent program listed in the John S. McCain National Defense Authorization Act for Fiscal Year 2019. RIC maintains a website with additional information of MFTP. A full definition of MFTP can be found there.
Management Plan – A document that specifies the actions that will be taken to prevent a potential conflict of interest from influencing decision making or performance of institutional responsibilities, including the design, conduct, and reporting of research.
Other Support – For the purpose of this procedure, this includes any resources and/or financial support from any foreign or domestic entities that is related to an investigator’s research and that have NOT been sponsored through USU Sponsored Programs Office. Examples include but are not limited to financial support for laboratory personnel (student, visitor, or employee support) and/or high-value items that are not freely available (e.g., biologics, chemicals, model systems, technology, office/laboratory space, etc.).
Outside Interest – Personal, professional, commercial, or financial endeavors a Researcher may undertake with an entity/organization external to USU in which the same professional expertise, service, or knowledge provided to USU are utilized, and which are not a part of a USU administered research project.
Public Health Service (PHS) – an operating division 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)
Researcher – Any individual involved in any aspect of the performance of research (i.e., design, conduct, or reporting) or submits proposals to external sponsors (including for instructional or other sponsored activities).
Research Conflict of Interest Review Subcommittee (RCIRSC) – The RCIRSC is comprised of select members of the COI Committee and has the authority to develop Management Plans for FCOIs if and when the office of Research Integrity and Compliance (RIC) determines additional review is necessary.
Significant Financial Interest (SFI) – Any financial interest that is held by the individual, their spouse/domestic partner, or dependent children, that is reasonably perceived to be related to the individual’s USU responsibilities, received from the entity in the twelve months preceding disclosure (unless otherwise specified in disclosure instructions), when aggregated, exceed $5,000, and where one of the following are true:
- Interests in publicly traded entities.
- Compensation (salaries, consulting fees, honoraria, paid authorship, etc.) and the value of any equity interest (stock, stock option, or other ownership interest) in the entity.
- Interests in non-publicly traded entities:
- Compensation (salaries, consulting fees, honoraria, paid authorship, travel, etc.); or
- Any equity interest (e.g., stock, stock option or other ownership interest).
- Intellectual property rights and interests (e.g., patents, copyrights) upon receipt of income related to such rights and interests.
Exemptions. The following are NOT defined as significant financial interests:
- Salary, royalties, grant support or other compensation from USU;
- Income from seminars, lectures, or teaching engagements or service on advisory committees or review panels for public or non-profit entities;
- Royalty income from intellectual property rights arising out of USU employment that are assigned to organizations created to manage such rights on behalf of USU;
- Income from investment vehicles, such as mutual funds or retirement accounts, as long as the individual does not directly control the investment decisions made in these vehicles.
- If an equity interest that, when aggregated meets both the following tests: (a) is less than the regulatory limit ($5,000 for PHS agencies and Department of Energy (DOE), $10,000 for all other agencies) in value as determined through reference to public prices or other reasonable measures of fair market value, and (b) is less than five percent ownership interest in any single entity; and intellectual property rights (e.g., patents, copyrights or royalties from such rights).
Procedures
RIC is responsible for reviewing all Researcher disclosures, determining if the interest represents a COI, and ensuring that all such disclosures are reviewed under the procedures outlined below.
This procedure applies to all individuals with a research appointment, including all research staff and those who submit proposals through Sponsored Programs, regardless of funding. Specific funding agencies may have their own policies related to COI and USU will follow all sponsor requirements. For example, PHS, DOE, the National Science Foundation (NSF), and the National Aeronautics and Space Administration (NASA) require grantee institutions to review all COI disclosure statements (listings of significant financial interests, externally funded and reimbursed travel, and foreign affiliations for Researchers and immediate family members) for all Researchers participating in funded research for the respective agencies; identify any conflicting interests and ensure that it has been managed. If a conflict is found to be unmanageable, USU is required to report to PHS, DOE, NSF, or NASA the existence of the conflicting interest.
Every COI shall be appropriately reviewed and managed by USU according to a conflict Management Plan prepared by the employee and approved by the employee's immediate supervisor and dean or vice president (as appropriate). Likewise, in accordance with USU Policy 545 Individual Conflicts of Interest, every COI shall be appropriately reviewed and managed as outlined below.
A. Disclosure Requirements
The COI review process involves the identification and disclosure of Outside Interests by USU Researchers. Researchers are required to submit a COI Disclosure via the Kuali COI module at the following times: (1) upon hire, (2) on an annual basis, (3) upon award of a sponsored project if a financial entity has been previously disclosed, and (4) within 10 business days of the Researcher becoming aware of a new SFI, externally funded or reimbursed travel, and/or a foreign appointment or activity as described in the COI disclosure form. Because disclosures are part of the workflow approval process, all COI disclosure submissions are required within 10 business days of notification from RIC or other USU offices. Submissions should include the nature and magnitude of the Outside Interest. Researchers will receive an annual reminder to update their disclosures and a reminder when a new project is awarded through SPO.
Outside Interests, or potential conflicts of interest relevant to the integrity of the research include, but are not limited to, the following (see definition of Significant Financial Interest, Externally Sponsored or Reimbursed Travel, Foreign Talent Program, and Foreign Affiliations, and Other Support):
- Ownership (e.g., equity, shares or stock options) in an outside company or other entity that has activity related to the research
- Compensation, other payments or items of value from an outside entity;
- Proprietary and/or financial interest related to the research including, but not limited to, a patent, trademark, copyright or licensing agreement;
- Externally sponsored or reimbursed travel; and
- Paid or unpaid activities and relationships (e.g., serving in a leadership position for the agency or company sponsoring the research, volunteer activities, consulting or serving on a scientific advisory board).
B. Initial Reviews and Approval
All negative disclosures (no reportable relationships or entities) will be automatically approved by the Kuali system.
RIC will review all Researcher disclosures that contain a positive reportable relationship or entity. If more information is required, the disclosure will be returned to the Researcher. Resubmission of the disclosure will be required within 10 days. If the Researcher has questions, they should contact RIC for clarification.
RIC will review each relationship to determine if a potential COI is present. RIC will consider the following factors in determining whether a conflict exists:
- The nature and extent of the research and an Investigator’s role on a project;
- The nature of the Researcher’s research activity, including whether it relates to basic or fundamental research directed at understanding basic scientific processes;
- Whether the research involves intellectual property linked to the SFI;
- Whether the research could affect the value of the SFI;
- The amount of the SFI; and
- Where the SFI is in another company, whether the Researcher’s SFI could result in the Investigator influencing company decisions, or whether the research could have a significant impact on the company’s business or financial outlook.
RIC will further evaluate whether the Outside Interest could:
- Directly and significantly affect the design, conduct, or reporting of USU research (including sponsored or unsponsored research) or present the appearance of doing so;
- Bias decision making while performing university or research duties;
- Impact the Researcher’s research or educational activities; or
- Present a COC.
If a potential conflict or the appearance of one is determined, the Researcher and their supervisor (typically the Department Head or Dean) will be notified so that a COI Management Plan can be initiated.
Potential conflicts unrelated to research will be referred to University Ethics and Compliance for review.
C. Foreign Entity Screening
RIC will screen all entities listed on the disclosure to ensure they are not sanctioned or embargoed by the U.S. government. Additionally, the screening will determine if there are other export control related concerns (collaborations, foreign travel, foreign visitors, etc.). Please see the USU Export Control Manual and Policy 590 Export Controls for more information.
USU does not allow any of its Researchers to participate in a Malign Foreign Talent Program. See RIC’s Foreign Talent Recruitment Programs webpage for more information.
D. COI Management Plan
For potential conflicts of interest, a Management Plan will be initiated. RIC will provide a description of the potential conflict. The Researcher and their Department Head, with the assistance of RIC, will develop a plan to manage the potential conflict.
Potential management methods include, but are not limited to:
- Public disclosure of financial conflicts of interest (e.g., when presenting or publishing the research);
- Appointment of an independent monitor capable of taking measures to protect the design, conduct, and reporting of the research against bias resulting from the financial conflict of interest;
- 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); or
- Severance of the relationships that created the financial conflict
The final Management Plan will be reviewed and approved by the Researcher, the Researcher’s Department Head and/or Dean, RIC, and other relevant parties [e.g., Institutional Review Board (IRB), RCIRSC, or others] if deemed necessary by RIC.
For potential COC, an Outside Interest review will be initiated. As the Researcher’s supervisor (Department Head and/or Dean) is best able to evaluate how an Outside Interest relates to a Researcher’s professional service and impacts a Researcher’s institutional duties and time commitments, they will determine if a COC is present. If the supervisor determines that a COC is present, a Management Plan will be initiated as described above.
If necessary, the Management Plan will be shared with relevant entities, including but not limited to Technology Transfer Services (TTS), IRB, Institutional Animal Care and Use Committee (IACUC), and funding agencies.
Researchers are responsible for implementing their COI Management Plan and ensuring it is being followed. Supervisors are also responsible for monitoring Management Plan compliance. Supervisors must conduct a review of the COI and Management Plan at least once per year. To facilitate this review, Researchers and Department Heads will receive an annual reminder to renew their Management Plan
Both the Researcher and the supervisor are responsible for reporting any changes or incidents that affect or could appear to affect the COI or its management to RIC within 10 days. The supervisor should discuss any concerns they have about the Management Plan or any potential issues of noncompliance with RIC
E. Human Subject Research
For COIs involving research with human participants, the Management Plan will also be reviewed by the IRB alongside any affected protocols. Changes or incidents that affect or appear to affect the research of human participants will be reported to the IRB by the Researcher and/or RIC. The IRB will conduct an annual review of all COI Management Plans involving research with human participants. To aid the IRB with this task, RIC will provide the IRB with a report, at least annually, of all COI Management Plans involving research with human participants
RIC will assist in developing a Management Plan when a potential or actual COI is identified. Methods implemented by RIC when providing management of COIs involving human subjects research may include, but are not limited to:
- The rebuttal of a presumption, based on the Association of American Medical Colleges standard, that USU should not move forward with a proposed human subjects research project in the presence of a COI.
- Identification of the Researcher, department head and dean responsible for ensuring the requirements of the COI Management Plan are followed
- Formal recusal by a Researcher from their chain-of-authority over a project and from authority over salary, promotions, space, or trainee assignments.
- Disclosure of the COI: (a) to other entities conducting research in a multi-site study; (b) to sponsors, either as required under regulation, or as a best practice, or (c) in the informed consent process.
- Formal commitment by the Researcher to disclose the COI in public presentations and publications.
F. Research Conflict of Interest Review Sub-Committee (RCIRSC)
If RIC determines a COI and/or Management Plan requires additional review, the RCIRSC will be established and tasked with assisting in the development of an effective Management Plan. Additional review may be needed in cases where RIC and the Researcher/Department Head disagree on a proposed Management Plan, the COI is such that a Management Plan would require a Researcher to give up or alter an area of study or consulting activity, the COI relates to an entity that is or would like to do business with USU, or in other cases where RIC determines additional viewpoints and guidance are needed in developing an effective Management Plan. The RCIRSC will be composed of a subgroup of members from the Conflict-of-Interest Committee and additional. Faculty representatives will also be included. If a COI is unable to be effectively managed, the matter will be referred to the Vice President for Research.
A report will be provided by RIC annually to the Vice President for Research of all research-related COIs and Management Plans
G. Noncompliance
Failure to disclose a COI or adhere to a COI Management Plan, or a supervisor’s failure to perform the supervisory and management responsibilities and roles set forth by USU policy and/or COI Management Plans may result in, but is not limited to, notation of such failure in performance reviews, removal or reassignment of job responsibilities, termination of employment, and criminal or civil prosecution under applicable state of federal law. See USU Policy 407.2: Academic Due Process: Sanctions and Hearing Procedures. RIC and the Vice President for Research will lead investigations of noncompliance, and other USU personnel, groups, and offices may also be involved, including General Counsel, the President of USU, IRB, IACUC, IBC, and others.
H. Training
- COI training via the ILS “COI for Researchers” module is required for all USU Researchers at the following frequency:
- Upon hire at USU
- Annually, as part of the annual USU compliance training cycle.
- Prior to approval of a COI Management Plan, if training is not up to date
- For PHS and DOE funded Investigators, RIC will remind Researchers of the training requirement at the time they are awarded funding. Training must be completed prior to conducting research
- Training will also be required when:
- COI policies are revised in a manner that changes Researcher requirements
- A Researcher is non-compliant with financial COI policies and procedures.
I. Other Ways Information on Outside Interests is Identified
Sponsored Project Proposals - Every proposal for external funding requires submission to the SPO via the Kuali system. The proposal submission requires the Researcher to certify whether a conflict exists. If a conflict exists, an up-to-date disclosure will be required prior to award set up. A new disclosure must be submitted for each sponsored research project awarded if a financial entity has been previously disclosed. Proposals to PHS, NSF, DOE, or NASA require an up-to-date disclosure (i.e., a disclosure submitted within the previous 12 months) prior to proposal submission. If a conflict with that project is identified, then an approved Management Plan must be in place prior to award set-up. Any unmanaged FCOI related to PHS, NSF, DOE, or NASA research will be reported to the respective agency in accordance with their individual policies.
Upon proposal submission to the SPO, Researchers are also required to certify that all subrecipients have an active and enforced COI policy, or that they will agree to abide by USU’s policy and related procedures.
IRB Application and Review - In accordance with the USU IRB Standard Operating Procedures, the IRB application shall include questions designed to identify any potential individual COI that may arise in connection with the study. The Researcher is required to disclose any potential COI related to the proposed study. In addition, potential COIs may also be identified by IRB members, reviewers, or others involved in the protocol application, review, and approval process
Positive disclosures of individual conflicting interests shall be referred by the IRB to RIC for review. If a determination is made that the disclosure constitutes a potential COI, RIC will work with the Researcher so that the conflict can be fully disclosed and managed or eliminated, as required under federal guidelines. Any identified conflicts not already disclosed in the Researcher’s Kuali COI disclosure will be added to the disclosure by the investigator and any resultant Management Plan will be processed and stored by RIC using the previously described process. No research for which a COI has been disclosed shall be conducted under an IRB-approved protocol until a COI Management Plan has been approved for the work.
Other Methods – Information about potential COIs can also be reported to RIC by other individuals or USU offices, such as department heads, the Purchasing Office, TTS, or other concerned individuals
J. Guidelines
The following guidelines are not inclusive and are not without exception. They provide examples of potential conflicts and processes for resolving them.
- USU employees in a position to influence a USU business decision for which they might receive material benefit should disclose the nature of the conflict to others involved in the decision. Whenever possible, those with potential conflicts should remove themselves from involvement in the decision. If the individuals should continue to participate in the decision process, discussion with supervisors and documentation of the potential conflict should be presented to the appropriate dean or department head
- USU members are regularly involved in consulting activities from which they profit financially. As a rule, such activities are not a conflict as long as:
- USU resources (laboratories, studios, equipment, computational facilities and/or human resources) are not more than incidentally used without reimbursing USU.
- Such activities do not unduly interfere with the time and energy committed by the individuals to their primary responsibilities to USU. The allowable amount of time dedicated to consulting will be governed by Policy 377 Consulting Service. USU members should adhere to the understood maximum of one day per week.
- Such involvement does not inhibit the publication of research findings developed in the course of the individual's regular USU activities
- USU actively encourages involvement in professional organizations, panels, advisory commissions, and government, charitable and community organizations. However, such involvement should not become so dominant that USU members no longer effectively satisfy their responsibilities to USU. The counsel of colleagues should be regarded as a valuable source of detached perspective on such conflicts of commitment.
- USU members should not engage in direct competition with USU either personally or through a firm in which they have a substantial interest. For example, such a circumstance may arise when an individual solicits a research award for which USU is a competitor or would have been a competitor had the individual properly acted as an agent of USU. In order to avoid such potential conflicts, the individual should consult the appropriate dean or department head.
- Before contemplating outside employment or consulting activities, USU members should disclose to the appropriate dean or department head potential conflicts of commitment or interest.
- Faculty members must exercise prudence in directing students and supervised employees toward activities from which the faculty member may financially benefit. The potential conflict is obvious, and faculty are encouraged to consult their dean, department head or colleagues for an independent evaluation of the activities' educational merits.