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.
According to USU’s Policy 307 – Conflict of Interest, a conflict of interest exists when a University employee owes a professional obligation to the University, which is or can be compromised by the pursuit of outside interests. Types of conflicts of interest that may exist include:
- Financial conflict – for example, an employee has a financial interest in a company that is funding research in his/her lab.
- Conflict of commitment – for example, an employee has committed more than 100% effort to a range of projects.
- Conflict of allegiance – for example, an employee’s personal interests may create a bias in his/her discharge of University duties.
- Personal connections – for example, an employee takes actions in order to help a relative or close acquaintance.
USU does not take the view that a conflict of interest is inherently bad for the University. In fact, employees who are appropriately engaged in outreach to the community, industry and their professions will often have a conflict arise.
Each USU employee must complete an annual Conflict of Interest Disclosure.
Abstention– The researcher does not participate in the project as a University employee but acts only in his/her role in the sponsoring organization.
Balance – Diverse interest groups (including non-University third parties) are included in oversight of the project.
Divestiture – The researcher removes the conflict by forfeiting his/her interest in the sponsoring organization/licensee or receipt other forms of compensation from the company.
Immediate family – For the purposes of this policy means spouse/domestic partner and/or dependent children.
Institutional Conflict of Interest (ICOI) – A conflict of interest exists whenever the financial interests or holdings of the institution or the personal financial interests or holding of institutional leaders (those with direct authority over the allocation of institutional resources), might affect or reasonably appear to affect the design, conduct, reporting, review, or oversight of human subjects research.
Institutional Leaders (IL) – Those with direct authority over the allocation of institutional resources, including, but not limited to: President, Provost, Vice Provost, Vice Presidents and Associate Vice Presidents, Deans, Department Heads, Center Directors; including those holding positions in an interim capacity who are in a position to directly influence salaries, appointments, resource allocation or oversight of human participant research, including chairs and directors of the Institutional Review Board, Conflict of Interest Committee, and other committees designated by the Director of Research Integrity and Compliance (DRIC). Members of the USU Board of Trustees are governed by a separate conflict of interest policy and are not governed by this policy.
Individual Conflict of Interest – A conflict of interest exists when a University employee owes a professional obligation the University, which is or can be comprised by the pursuit of outside interests.
Mediation – May include oversight by the immediate supervisor, the dean or vice president (as appropriate), or a committee appointed by the immediate supervisor. In no case shall a researcher have direct financial oversight of a project sponsored by an organization in which he/she has a financial interest, nor shall any employee under the direct control of the researcher have financial oversight.
Prohibition – The researcher permanently withdraws from the secondary interests.
Public Disclosure – The informed consent form (as administered through the Institutional Review Board) shall disclose the financial interest or licensed technology) to the participants, and any publication of study results shall disclose such financial interest.
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. PHS Awarding Component means the organizational unit of the PHS that funds the research that is subject to this subpart (42 CFR 50).
Researcher – Any individual involved in any aspect of the research (i.e. design, conduct, or reporting).
Significant Financial Interest (SFI) – Any financial interest that is held by the individual, his or her 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, when aggregated, exceed $5,000 for PHS agencies or $10,000 for all other agencies, 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.
- Go to https://research.usu.edu/kuali/
- Click “Launch Kuali”.
- At top of screen, click “COI”.
- Click green box “+ Update Annual Disclosure”.
- Go through your COI Disclosure.
- Go to https://research.usu.edu/kuali/
- Click “Launch Kuali”.
- At top of screen, click “COI”.
- On the left-hand side, click “Review Disclosures”.
- Click on the name of the person under “Submitted By” to see the disclosure.
- Review the listed financial entities and selected management options. Keep in mind how those responses pertain to any Project Declarations (ie Institutional Proposals).
- As you look through the disclosure, you can click the “+ Comment” buttons to add comments. Please be sure to enable the option to make your comment visible to the reporter (PI) at the bottom of the page.
- On the right-hand side you can click “Review Comments” to see your own comments and comments left by other reviewers.
- Once you have completed your review, on the right-hand side you will be able to either click “Approve” or “Send Back to Revise” (if you made comments).
- Note, the review process will continue until either the management plan is approved or the project proposal is rejected due to an unmanageable conflict of interest.
- If you have financial entities, the recently updated COI disclosure no longer requires you to complete a “COI Management Plan”. It is now embedded into the disclosure.
- Each new Sponsored Programs proposal requires an updated COI disclosure.
- You only need to declare a project if it poses a potential COI with your listed financial entities.
- Funds cannot be released until an updated COI disclosure is completed.
- If a new conflict of interest arises or an existing conflict of interest changes, your COI disclosure must be updated within 30 days.
- Once updated, your annual disclosure date will reset to 365 days from the date.
PHS-funded researchers will receive training related to financial COI via the CITI COI module. Training must be completed prior to conducting research and at least every five years thereafter. Training will be required immediately when:
- Financial COI policies are revised in a manner that changes researcher requirements.
- A researcher is new to the organization.
- A researcher is non-compliant with financial COI policies and procedures.
- Go to the CITI website.
- Click “Register” in the upper right corner of the page.
- Under “Select Your Organization Affiliation,” type Utah State University in the search box. Select Utah State University from the dropdown menu. Continue to step 2 on the CITI website.
- Enter your personal information. A secondary email address is optional but recommended. Continue to step 3 on the CITI website.
- Create your username and password. Select a security question and answer. Continue to step 4 on the CITI website.
- Enter your country of residence and select it from the dropdown menu. Continue to step 5.
- Indicate your interest in receiving Continuing Education Unit credit for completed CITI Program courses. Select an answer about participating in research surveys. These are voluntary programs but you must answer the questions to proceed. Continue to step 6 on the CITI website.
- Provide answers to the required questions (starred). Non-starred questions are optional. The institutional email address should be your email address affiliated with USU. If you do not have an office phone, please enter a mobile or home number. Continue to step 7 on the CITI website.
- Select “Conflict of Interest (COI)” and go to the next page.
- Click “Finalize Registration.”
- Go to the CITI website and log in.
- Under “Main Menu/My Courses “scroll down to the bottom.
- Under “My Learner Tools for Utah State University”, click Add a Course.
- Select “Conflicts of Interest” and click next.
- Select “Yes, enroll me in the Conflicts of Interest Course” and click “Next”.
- You should now be enrolled for that course.
The Division of Research Integrity and Compliance (DRIC) is responsible for reviewing all disclosures, determining if the interest represents a COI or ICOI, and ensuring that all such disclosures are reviewed under procedures outlined below.
Public Health Service (PHS) funded research requirements call for grantee institutions to: review all financial disclosure statements (listings of significant financial interests for researchers and immediate family members) for all researchers participating in PHS funded research; and to report to PHS the existence of a conflicting interest found by the institution and ensure that it has been managed.
Every COI shall be appropriately managed by the University 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 #307 Conflicts of Interest, every ICOI shall be appropriately managed by the Institutional Conflict of Interest Committee (ICOIC) as outlined below.
Because disclosures are part of the workflow approval process, if SFIs are held, all submissions are required within 5 business days of notification and should include the nature and magnitude (within preset dollar ranges) of the outside interest.
Failure to comply with COI policies may subject offenders to potential sanctions ranging from verbal warning to termination of employment per USU Policy 407.2: Academic Due Process: Sanctions and Hearing Procedures.
Researchers with a COI or perceived conflict which require a COI Management Plan will receive training related to financial COI via the CITI COI module. Training must be completed prior to approval of the management plan and at least every five years thereafter unless the conflict has dissolved.
A management plan may include:
- Requiring full disclosure of all interests so that others are aware of potential conflicts and can act accordingly.
- Monitoring the research or checking research results for accuracy and objectivity.
- Removing the person with the conflict from crucial steps in the research process, such as the interpretation of data or participating in a particular review decision.
The recently updated COI disclosure is now embedded with a management plan. As you enter in financial entities, it will walk you through the management process. Once your COI disclosure is complete, the COI officer will send it to your department head and college dean for review and approval. Once approved, they will send it back to the COI officer for final approval.
Information relevant to outside interests is identified the following ways:
- Sponsored Project Proposals
Every proposal for external funding requires submission to the Sponsored Programs Office (SPO) via the Kuali system. The proposal submission requires the researcher to certify whether a conflict exists. If a conflict exists, a disclosure will be required prior to proposal submission. If the proposal is NIH funded, and a conflict is disclosed, it will not be submitted until the management plan as been approved. occurs. A new disclosure must be submitted for each sponsored research project submitted to SPO.
For sponsored research projects from non-governmental entities that also involve human participants, SPO will identify and provide pertinent information about the sponsor of the research to the DRIC as well as the Director for the HRPP for assessment with regard to existing USU business interests. The DRIC will ensure the completion of the COI disclosure as well as the COI management plan if required. The management plan will then be provided to the IRB for review. The IRB will make the final determination with regards to the COI management plan regarding third party entities whose products, technologies or personnel will be involved in the conduct of the human subjects research.
- IRB Application
In accordance with the USU Institutional Review Board’s (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 IRB shall identify all projects in which a product or service is to be used, but which are not directly sponsored by the outside entity providing the product or service can trigger initiation of an ICOI assessment.
Positive disclosures of individual conflicting interests shall be referred by the IRB to the DRIC so that the conflict can be fully disclosed and managed or eliminated, as required under federal guidelines. 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.
- Technology Transfer Report
In cases where conflicts arise due to technology commercialization activities, appropriate management can normally be established by providing for segregation of decision making for the University’s financial activities (e.g., management of equity holdings or royalty revenues) and its research activities, so that they are separately and independently managed.
The use of technology that Technology Transfer Services (TTS) has licensed out to an organization which sponsors research at USU involving human subjects conducted at USU or reviewed by USU’s IRB, whether it results in income to USU or not, shall be deemed to give rise to an ICOI.
Quarterly, the TTS Office will provide the DRIC a report containing a listing of all active technologies that involve a non-governmental outside entity. The DIRC will cross-match the records with the DSP report to discern any situation in which the stated threshold is or is expected to be met during the duration of the research.
The COI review process involves the identification and disclosure of outside interests by all individuals with a research appointment including all research staff, regardless of funding. These individuals are required to submit a COI Disclosure via the Kuali COI module on an annual basis or upon proposal development through the Sponsored Programs Office (SPO). If the researcher indicates a conflict exists, the disclosure will be reviewed to determine whether a conflict exists with the sponsored research and management of the conflict is required. Researchers will receive an annual reminder to update their disclosures.
Identification and disclosure of 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):
- 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 (consulting fees);
- Proprietary and/or financial interest related to the research including, but not limited to, a patent, trademark, copyright or licensing agreement; 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).
If a COI exists, the researcher must indicate how the conflict will be managed within the COI disclosure in Kuali. This disclosure will be routed to the researcher’s department head and dean for review then back to the DRIC for approval.
Methods implemented by the DIRC when providing management of COIs 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 an 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 his/her 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.
- Managed conflicts will require completion of Financial Conflict of Interest training via CITI.
The Division of Research Integrity and Compliance (DRIC) is responsible for reviewing all disclosures, determining if the interest represents a COI or ICOI, and ensuring that all such disclosures are reviewed under procedures outlined below. The DRIC has responsibility for any required reporting of ICOI and associated management plans, and shall provide to the Vice President for Research, as the Institutional Official, an annual report of all disclosures and management plans related to Human Subjects Research directly involving USU.
When USU licenses technology or other intellectual property, it may receive equity in a company as a result of that license and/or royalty or other fee as compensation for the use of that intellectual property. An institutional conflict of interest is created if a researcher conducts human subjects research utilizing a drug, device, biologic, or other item on which USU owns intellectual property, has licensed the intellectual property, or receives royalties or other fees related to the USU intellectual property.
For every human subjects research project where a non-governmental third-party entity is involved, the DRIC will determine if either the institution or any IL holds an interest with that third party. No less than quarterly, DSP will identify and provide pertinent information about non-governmental sponsors with human subjects research to the DRIC for assessment. Upon receipt of this report, the DRIC will determine if any matches exist between the DSP report and a similar report prepared by the TTS Office containing current activities. If a match occurs, the finding will be forwarded for review by the Institutional Conflict of Interest Committee (ICOIC).
Institutional conflicts involving research with human participants must be approved by the ICOIC, the Provost or an authorized designee of the Provost as outlined in USU #307 Conflicts of Interest. Management plans shall be appropriate to the COI, and may employ management approaches including, but not limited to the following: avoidance; public disclosure; balance; mediation; abstention; divestiture; prohibition; or no action required (see definitions).
In reviewing potential ICOI, the DRIC will evaluate the following factors: (a) level of risk to research participants; (b) potential effect on the integrity and objectivity of the proposed human subjects research; (c) level and type of financial interests or relationships held by the university and or the IL; (d) how direct and immediate an IL’s authority is over the research or principle researcher and research staff involved in conducting the research; (e) whether there are adequate internal controls in place to prevent the disclosed financial interest from affecting decisions about the research; (f) status of the outside organization (whether it is privately or publicly held, whether it is for-profit or non-profit, and whether USU has a direct equity position in the organization); and (g) perceived reputational or existential risk to USU.
When the DRIC assessment of the ICOI identifies matches between outside interests identified with financial interests held by USU, they will provide the disclosure to the ICOIC along with any proposed management plan and/or review of existing internal controls that would provide adequate management of the ICOI. In accordance with USU Policy 307.3.3 University Oversight of Conflicts of Interest, the ICOIC will assemble to review the conflict and develop an appropriate management plan. The ICOIC shall meet as required to: (a) review all disclosed ICOI related to Human Subjects Research; (b) review all ICOI management plans submitted for approval; (c) recommend elimination of conflicts as it deems necessary; and (d) monitor all active management plans.
After its review and action, the ICOIC shall forward to the IRB any approved plan or recommendation. Copies of this document shall also be provided to the department head and dean of the affected unit(s). The IRB shall have final authority to accept and have the management plan implemented, to alter the management plan, or to deny the management plan and reject the study.
In cases where COIs arise due to gifts or holdings in USU’s endowment, appropriate management has been established through internal controls that are included in USU Policy 517, Investment Policies. In exceptional cases where the ICOIC finds that a conflict cannot be adequately managed, it may recommend that the University divest itself of its equity position, abstain from participating in research related to the conflict, or otherwise reduce or eliminate the conflict.
Examples of conflicts that require disclosure.
- A University employee owns a company, hires a student(s) to work for that company, and has supervisory responsibility over the student’s activities both at USU and at the workplace.
- A University employee is a principal investigator on a project and subcontracts to his private company.
- A University employee owns a company that may be doing business with the University and makes purchases from that company through a contract or grant.
- A licensee contributes as a quid pro quo.
- A University employee (or close relative) has a financial interest in the licensee or sponsor (its parents, subsidiaries, and affiliates).
- A University employee has a major consulting agreement with the licensee.
- A license is to a University employee’s own company.
- A University employee has fiduciary responsibilities to shareholders of a company (by, for example, being an officer or director of the company) that is or may become a licensee of University technology or a sponsor of University research.
- A license is coupled with sponsored research.
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 follow tests: (a) is less than the regulatory limit ($5,000 for PHS agencies, $10,000 for all other agencies) in value as determined through reference to public prices or other reasonable measures of fair market value, or (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).
- Association for the Accreditation of Human Research Protection Programs, Standard I.6.A
- NIH Financial Conflict of Interest
- NSF Conflict of Interest and Standards of Ethical Conduct Manual
- NSF 10-1, Chapter IV – Grantee Standards
- NSF Grant Policy Manual (95-26) Section 510, “Conflict of Interest Policies”
- Public Health Service, Title 42: Public Health, Part 50 – Policies of General Applicability
- USU Institutional Review Board Standard Operating Procedures
- USU Policy #307: Conflicts of Interest
- USU Policy #407: Academic Due Process: Sanctions and Hearing Procedures
- USU Policy #583: Research
- USU Policy #584: Human Participant in Research
- USU Policy #517: Investment Policies