Conflict of interest

Conflict of interest reporting for new employees

Per federal and Kansas Board of Regents policies, the KU COI reporting system requires faculty and unclassified professional/academic staff members to declare whether they, their spouse, or other household members have any significant financial interest related to their own research or educational activities. The standard of "conflict" is whether an independent observer would conclude the appearance of undue influence or a conflict of interest. Additionally, individuals report any time commitments outside their university responsibilities related to the same activities. Consulting must be reported though this system, as well as reviewed and approved in advance by the employee's department head/unit director, by the appropriate dean or vice provost, and by the provost and executive vice chancellor.

The majority of employees have no significant financial interests or time commitments to disclose, and the certification submission at the end of the process completes their report. Individuals who declare that they have significant financial interests or time commitments related to their university responsibilities will disclose details through the secure, confidential system.

Certification of disclosed financial interests and time commitments

New faculty and unclassified staff members will receive an email that contains a link to the COI reporting system. Additionally, faculty and staff members who are identified as investigators on Public Health Services (PHS) proposed or funded projects may be contacted by Pre-Award Services or Research Integrity staff to initiate a research certification. 

If you haven't received an email request to complete your annual COI report within two weeks of employment, please contact coi@ku.edu.

Your first certification in the COI reporting system will take a bit longer than subsequent certifications because you will need to become familiar with the reporting format and enter information about your significant financial interests, if any. Please plan accordingly and refer to the COI disclosure instructions elsewhere on this page for assistance.

Once you have completed an initial certification, your next annual certification will consist of simply confirming that your record is up to date, if you have nothing further or new to disclose.

Conflict of interest requirements for Public Health Service agencies

In compliance with federal regulation 42 CFR 50, Subpart F, Promoting Objectivity in Research, the University of Kansas requires investigators who work on or submit project proposals to PHS-compliant agencies to follow the procedures below.

Definition of investigator

As per 42 CFR 50, Subpart F §50.603, the federal definition of investigator is "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 the PHS, or proposed for such funding, which may include, for example, persons who are sub grantees, contractors, consortium participants, collaborators or consultants." 

The PD/PI is responsible for identifying individuals who will be participating at the investigator level on the project. Usually, at a minimum, the PI, co-I and key personnel are designated investigators. 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.

Requirements

1. Financial Conflict of Interest (FCOI) training: Award funds for PHS-compliant projects must be withheld until all project investigators have completed the FCOI training. To satisfy the training requirement for KU-Lawrence, training is provided through the CITI Program. 
   • See instructions below for enrolling in the KU FCOI course.
   • Modules must be completed with a passing score of at least 80%.
   • The estimated completion time is 30 minutes.
   • The training is valid for four years from completion.  
2. Certification of disclosed financial interests per PHS-compliant project: Each investigator must submit a special conflict of interest certification ("Research Certification") prior to each PHS-compliant proposal submission. This requirement must be completed for all investigators associated with the project prior to the availability of funds for PHS-compliant projects pending or renewing the award.
3. Research certification process: In consultation with the PI, pre-award staff will generate an email that contains a link to the COI reporting system to each investigator on the project. All investigators must complete their certifications in the myDisclosures system before the proposal is submitted.

Instructions for enrolling in the KU FCOI course

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.

Public Health Service agencies

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.

Conflict of Interest Committee

Conflict of interest disclosures for the KU Lawrence campus are reviewed by a representative advisory committee, which makes a recommendation to the Vice Chancellor for Research and the Provost about the management of a conflict situation.

The Conflict of Interest Committee will consist of five faculty and unclassified staff members; a non-KU affiliate member; and ex officio non-voting members from the offices of the Provost, the Vice Chancellor for Research, and the Human Subjects Committee. Voting members are appointed by the Vice Chancellor for Research and serve rotating three-year terms. The Conflict of Interest Committee is not a policymaking body but can make policy recommendations.

Committee members or designated staff review each conflict of interest disclosure submitted and make recommendations as to whether an actual or perceived conflict of interest exists. The Conflict of Interest Committee may request additional information as necessary.

Conflict of Interest Committee recommendations are forwarded to the Vice Chancellor for Research and the Provost for final approval of the disposition of each potential conflict of interest situation. All information provided to the Conflict of Interest Committee will be maintained in strict confidence.

— Appendix A, KU-Lawrence supplemental policies to the Kansas Board of Regents Conflict of Interest and Time Policy (Nov. 12, 2004)