Conflict of Interest

• Investigators, defined as "the project director or principal investigator (PD/PI) and any other person, regardless of title or position, who is responsible for the purpose, design, conduct or reporting of research funded by the PHS or DOE, or proposed for such funding, which may include, for example, persons who are sub grantees, contractors, consortium participants, collaborators or consultants." 
• Affiliates and Collaborators from other institutions who are working on University projects may also be required to complete training. If the subrecipient or subcontractor is not a PHS or DOE compliant institution and has not signed a subaward accepting responsibility for oversight of COI requirements, then collaborators must demonstrate completion of COI training and disclosure through the University.

• Prior to engaging in research sponsored by a PHS or DOE Agency or PHS compliant entity; 
• Institutional Financial Conflict of Interest policies change in a manner that affects Investigator requirements;
• An Investigator is new to an Institution; or
• An Institution finds that an Investigator is not in compliance with the Institution's Financial Conflict of Interest policy or management plan.

Financial Conflict of Interest Training must be completed through the CITI Program and renewed every four years.

1. Go to the CITI program website and click "Log in."
2. Click "Log in through my institution."
3. Choose University of Kansas-Lawrence from the SSO list.
4. Log in with your KU online ID and password. If you have previously logged into CITI as a KU user, move to step 8.
5. Click the "Continue" button.
6. Select "I don't have a CITI Program account and I need to create one."
7. Select "Click here to create a new CITI Program account." A CITI account will be created and linked to your KU-Lawrence or KUMC login info, and you will be able to log in using SSO in the future.
8. On the main menu, make sure "University of Kansas-Lawrence" is selected.
9. Click on the "Add a course" link to complete enrollment.
10. Select question 4, Financial Conflicts of Interest (FCOI) courses. If you have never completed the FCOI training, select the "Initial KU Financial Conflicts of Interest" course. If you need to complete the 4-year retraining requirement, select the "Refresher KU Financial Conflicts of Interest" course.
11. Scroll down and answer "Not at this time" for the remaining questions.
12. Click the "Submit" button to complete registration; then complete the training.

1. Administration for Children & Families (ACF)
2. Administration for Community Living (ACL)
3. Agency for Healthcare Research & Quality (AHRQ)
4. Agency for Toxic Substances & Disease Registry (ATSDR)
5. Centers for Disease Control & Prevention (CDC)
6. Food & Drug Administration (FDA)
7. Health Resources & Services Administration (HRSA)
8. Indian Health Service (IHS)
9. National Institutes of Health (NIH)
10. Office of Global Affairs (OG)
11. Office of the Assistant Secretary for Health (OASH)
12. Office of the Assistant Secretary for Planning & Evaluation
13. Office of the Assistant Secretary for Preparedness & Response (ASPR)
14. Office of Public Health & Science
15. Substance Abuse & Mental Health Services Administration (SAMHSA)

Some non-PHS agencies have adopted the PHS regulations. Please consult directly with the private agency in question to clarify award terms.

All COI disclosures go through the myDisclosures system. A KU Online ID is required to log into the system. 

More information on the COI reporting system can be found in the guides on Policies and Procedures page.

As required by federal, Regents and University of Kansas policy, all faculty and unclassified staff and any other members of the KU community who are responsible for the design, conduct or reporting of research or educational activities are required to disclose relevant financial interests. Additionally, Regents and university policies require all faculty and unclassified staff to disclose external professional activities that entail time commitments, whether paid or unpaid.

A disclosure is the act of making new or unknown information known. In this case, it is a statement of your or your immediate family’s financial interests or time commitments, as qualified by federal, Regents and university policy.

A disclosure profile update is the process of providing new/confirming existing disclosures, noting institutional responsibilities, and providing context about how disclosures may relate to specific research projects in the myDisclosure system. Disclosure profile updates are issued upon hire, annually, and as needed for regulatory purposes. Faculty and staff should also complete a disclosure profile update within 30 days of acquiring a new significant financial interest (SFI).

A certification is a statement of assurance. In this case, it is a statement assuring that you listed all relevant disclosures and accurately reflected your current relationship with those disclosed entities. Certifications are created by the system annually and submitted through the disclosure profile update process.

myDisclosures is a web-based interface designed to collect and review certifications submitted by eligible KU faculty, staff and investigators. The online forms provide the criteria for reporting information about entities with which you have professional time commitments and/or significant financial interests that meet thresholds for disclosure. You will list each entity that meets disclosure criteria along with descriptions of your current relationship.

For example:

• You might have a time commitment and receive compensation for your work as a consultant for a nonprofit organization. 
• You may have no time commitment, but your spouse holds equity in a colleague's startup company.
• You could have no financial interest but have a time commitment as an officer of a professional organization.

The myDisclosures system saves your list of disclosures as a continuing part of your reporting record that you will update annually and when circumstances change, such as when you acquire a new significant financial interest or your current relationships change.

You will need details to disclose whether you, members of your immediate family (spouse and dependent children), personal household, or associate entities (e.g., corporations, partnerships or trusts) have consulting arrangements, significant financial or managerial interests, or employment in an outside entity whose financial or other interests would reasonably appear to be related to your university activities. The form asks questions regarding the amount of time spent and the value of the different interests you or your household members have within the last 12 months.

After making disclosure(s) and/or updates, the online reporting system will ask that you certify your disclosures are accurate and complete. Once you make this certification, your information will route electronically for review.

Faculty and unclassified staff must submit a certification annually and on an ad hoc basis as new significant financial interest arise. In addition, all investigators participating on proposed or awarded Department of Energy, National Nuclear Security Administration, or PHS-compliant sponsored projects must complete a disclosure profile update providing their disclosed financial interests at the time of proposal submission and progress reports. Periodic conflict of interest training is also required of these individuals.

The university is responsible for reviewing all disclosures and determining whether an outside interest constitutes a conflict of interest with university responsibilities. Your immediate supervisor will be asked to review your certification if you have made any disclosures. After supervisor review, the certification is routed for administrative review and, if necessary, to the Conflict of Interest Committee.

Kansas Board of Regents and KU-Lawrence policies require conflict of interest reporting by: 

• all faculty and unclassified academic and professional staff members.
• any other investigator on a sponsored research project who is responsible for the design, conduct or reporting of research.
   

"Conflict of interest" refers to reported financial, managerial or time commitment disclosures that may compromise, or have the appearance of compromising, scientific judgment, integrity of research data, fulfillment of professional duties, or the safety and welfare of research volunteers. A conflict of interest is not an indicator of ethical missteps or wrongdoing. Management plans are put in place to ensure transparency and protect individual and institutional integrity.

Conflicts can be individual or institutional in nature. Individual conflict of interest may be associated with financial incentives in research, business ownership, consulting, intellectual property development, outside employment, and commitment to external organizations. Institutional conflict of interest arises from financial interests of the university or senior officials that might color the review, approval, or monitoring of research.

It is important to note that potential conflicts arise frequently in university settings, often as part of legitimate professional development. Activities supported and encouraged by KU, such as consulting and commercialization of technologies, represent the fulfillment of the university's mission to translate scientific discoveries into beneficial products and services and may arise as potential conflicts. In these instances, individuals should not be concerned if their disclosures route for routine review. The more details an individual provides regarding the disclosures, the more quickly the COI office may complete its necessary review of the disclosed activities.

Types of Disclosures

eCompliance organizes disclosures within the following categories:

• Financial and managerial interests of equity (e.g., ownership, stock holdings, equity interests, loans). 
• Remuneration (e.g. salary, consulting fees, commissions).
• Intellectual property rights and interests (e.g., patents, copyrights).
• Sponsored travel (travel which is paid on behalf of the individual and not reimbursed to the individual so that the exact monetary value may not be readily available).
• Outside professional positions, paid or volunteer (e.g., board positions, consulting).

Such disclosures apply to: Faculty and unclassified staff and other investigators on sponsored projects. Additionally, individuals must report significant financial interests of immediate family (spouses and children) and other household members.

Review and management of disclosures: The Conflict of Interest Committee is charged with reviewing disclosures and determining whether a management plan is necessary to protect the interests of the individual and the university. An appropriate plan monitor, usually the individual's supervisor, is appointed to ensure compliance with the plan.

Conflict of time commitment exists whenever a faculty or staff member's external activities exceed reasonable time limits or whenever an unclassified staff or faculty member's primary professional responsibility is not to the university.

Standards for reporting: External time commitments for personal professional activity related to university responsibilities may need to be reported prospectively, as an external activity request (EAR), as well as in the myDisclosures reporting system. Examples of reportable activity include consulting, outside employment, public service, pro bono work, or service as an officer in an external entity.

Applies to: Faculty and unclassified staff
 

Reports must be filed:

• upon employment.
• annually in the fall, upon announcement from the Office of Research.
• upon submission of a Department of Energy, National Nuclear Security Administration, or PHS-compliant research proposal on which you are considered an investigator.
• on an ad hoc / update basis, within 30 days of acquiring a significant financial interest.

The university must be in compliance with Public Health Service (PHS) regulations, "Promoting Objectivity in Research," dated Aug. 24, 2012 and “Department of Energy Interim Conflict of Interest Policy Requirements for Financial Assistance,” dated Dec. 20, 2021. There are three requirements applicable to investigators on these projects.

1. Financial Conflict of Interest (FCOI) Training: Award funds for PHS-compliant, DOE or NNSA projects must be withheld until all investigators on the project have been trained. To satisfy the training requirement, KU has a CITI Program training module that takes about 30 minutes to complete. If you are an identified investigator, you will receive an email from coi@ku.edu with instructions on how to access the Financial Conflict of Interest (FCOI) course. Please complete the tutorial as soon as possible to ensure that your award funds are not delayed. Upon completion, your training will be certified for four years.
2. Certification of disclosed financial interests per PHS-compliant, DOE OR NNSA projects: Each investigators on a PHS-compliant, DOE or NNSA project will submit a disclosure profile update prior to each proposal submission, certifying that all disclosures are up to date.
   • Pre-award staff will generate an email that contains a link to myDisclosures for each investigator on the project. All investigators must submit their disclosure profile update in the online system before the proposal is submitted.
3. PI decides who is an investigator: The FCOI training and per-project disclosure profile update requirements apply to all "investigators" on PHS-compliant, DOE or NNSA proposed or funded projects. The PI is responsible for identifying individuals who will be participating at the investigator level on the project.

While the federal definition of investigator is quite broad, keep in mind that its application to an individual is dependent on the individual's contribution to the project and may not apply to everyone named on the project.

The KU COI system, myDisclosures, asks individuals to certify whether they, their spouse, dependent children, or other household members have any significant financial interests or time commitments reasonably related to their KU responsibilities. The majority of employees do not have reportable outside interests to disclose, and the certification submission at the end of the process completes their report.
 

Individuals who have significant financial interests or time commitments related to their university responsibilities must disclose certain details. Disclosures are generally considered confidential, although in the case of a managed conflict, funding agencies may require reporting and public availability of some details of the relationship. The purpose of a management plan is to outline how the conflict will be minimized and/or monitored.

"Supervisor Review" as used in the COI reporting system indicates that the supervisor has reviewed the individual's certification and agrees to the best of his or her knowledge that the filer is in compliance with the COI policy. The supervisor is invited to provide comments, which may include any concerns about outside activity, departmental support of the activity, and/or how the department is currently managing a potential conflict.

Failure to comply with reporting and disclosure requirements for conflict of interest and time commitments may have the following consequences:

1. Individuals will not be allowed to submit internal or external grant applications until they have complied. In addition, funded awards cannot be set up if any investigators on the project have not met reporting requirements.
2. Failure to comply may result in disciplinary action.

No. Approval for consulting is a separate process which is overseen by the Office of the Provost. The Regents policy, Commitment of Time, Conflict of Interest, Consulting and other Employment, describes both the external activity review process and conflict of interest reporting requirements. If a "consulting or other employment" activity has a financial component that exceeds the COI threshold, reporting in the conflict of interest system will be required in addition to gaining approval through the consulting request process.

Standards for reporting: Information and forms for approval of consulting and other outside work are available on the policies and resources page of the Office of Faculty Affairs website.

Applies to: Faculty and unclassified staff

Overseen by: The Office of the Provost

Yes. Individuals who submit grant applications must certify that they understand and have complied with the conflict of interest policies. Your signature on the certification form indicates that your financial interests and time commitments have not changed since your most recent conflict of interest report. Certification for grant submission is not a substitute for conflict of interest reporting.

For many years, state employees with certain kinds of responsibilities have been required to file an annual State of Kansas Statement of Substantial Interests (KS SSI) in accordance with the laws administered by the Kansas Secretary of State. More information about the KS SSI is available on the Kansas Governmental Commission website.