Frequently Asked Questions

Who is required to file Conflict of Interest (COI) reports?

Kansas Board of Regents and KUMC policies require conflict of interest reporting by all full and part-time faculty and unclassified staff and other individuals who are responsible for the design, conduct, or reporting of research, and certain sub-recipients of sponsored projects or awards from PHS compliant agencies

What is a conflict of interest?

"Conflict of interest" refers to situations in which financial or managerial interests or time commitments 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 depends on the situation and not on the character or actions of the individual.

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 frequently arise in university settings, often as part of desirable and legitimate professional development. Activities such as consulting and commercialization of technologies represent the fulfillment of the university's mission to translate scientific discoveries into beneficial products and services. KUMC encourages interactions that promote public benefit while ensuring the integrity with which those activities are accomplished.

Standards for reporting: 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 position, consulting)

What is a Conflict of Time Commitment?

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 institution.

Standards for reporting: External time commitments should be reported if they relate to university responsibilities. These include consulting, outside employment, public service, pro bono work, or service as an officer in an external entity.

How often is filing required?

Reports must be filed:

• upon employment,
• annually thereafter,
• upon submission of a PHS-compliant research proposal on which you are considered an investigator, and
• on an ad hoc / update basis as new situations arise.

Ad hoc / update reports: Regents policy requires ad hoc reporting of any new situations that may raise questions about conflict of interest. These activities should be reported as soon as they become known. If the issue pertains to federally funded research, government regulations require that the newly-disclosed conflict be managed, reduced, or eliminated, at least on an interim basis, within sixty (60) days of its identification.

How do I file my report in the new system?

You will receive an e-mail notification in late November or early December from the kucoisys@ku.edu mailbox instructing you to file an FY2013 Annual Certification of your significant financial interests and time commitments.

Your first Certification in the new COI reporting system may 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.

Quick and easy after the first certification: Most faculty and staff members will complete subsequent Annual Certifications in less than five minutes once an initial certification has been made in the new reporting system. After following the e-mail link and logging in to the COI reporting system, the individual will simply update any disclosures and certify OR certify that all disclosures are up to date.

What's new in the COI Reporting process?

For PHS-Sponsored Researchers:

The University must be in compliance with the new Public Health Service (PHS) regulations, "Promoting Objectivity in Research," by August 24, 2012. You may be listed as an investigator on a currently funded or proposed project sponsored by an agency that has adopted the new PHS regulations (hereafter "PHS-compliant" agency). There are three procedural changes applicable to investigators on PHS-compliant projects that will require your attention and participation.

1.  Financial Conflict of Interest (FCOI) Training. As of 8/24/12 award funds for PHS-compliant project must be withheld until all investigators on the project have been trained. To satisfy the training requirement, KU has produced an online tutorial that takes about 45 minutes to complete. If you are an identified investigator, you will receive an e-mail from kucoisys@ku.edu with a link to the KU tutorial. Please complete the tutorial as soon as possible to ensure that your award funds are not delayed. On completion, your training will be certified for four years.

2. Certification of disclosed financial interests per PHS-compliant project. As of 8/24/12, each Investigator on a PHS-compliant project will also need to submit a special conflict of interest certification ("Research Certification") prior to each PHS-compliant proposal submission, or prior to the availability of funds for PHS-compliant projects pending or renewing the award.

Research Certification process: After a PI initiates contact with pre-award staff about a proposal or renewal submission, pre-award staff will generate an e-mail that contains a link to the new COI reporting system to each Investigator on the project. All Investigators must submit their certifications in the online system before the proposal is submitted.

Your first Certification in the new COI reporting system may take a bit longer than subsequent certifications since you will need to become familiar with the reporting format and enter information about your significant financial interests, if any. Please plan accordingly.

Quick and easy after the first certification: Most Investigators will complete subsequent Research Certifications in less than five minutes once an initial certification has been made in the new reporting system. After following the e-mail link and logging in to the COI reporting system, the investigator will simply respond to a question about the relation of his or her disclosed financial interests, if any, to the current project and certify that all disclosures are up to date.

You will still need to file an FY 13 Annual Certification of your significant financial interests and time commitments. The process is basically the same as the Research Certification. If you have already completed a Research Certification and have nothing further to disclose, the Annual Certification will consist of confirming that your record is up to date.

3. PI decides who is an Investigator. The FCOI training and per-project Research Certification requirements apply to all "Investigators" on PHS-compliant 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, below, 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 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 subgrantees, contractors, consortium participants, collaborators, or consultants."

What are the PHS-compliant agencies?

For your information, the current list of PHS-compliant agencies, as of 8/10/2012:

• Agency for Healthcare Research and Quality (AHRQ)
• Agency for Toxic Substance and Disease Registry (ATSDR)
• Centers for Disease Control and Prevention (CDC)
• Food and Drug Administration (FDA)
• Health Resources and Services Administration (HRSA)
• Indian Health Services (IHS)
• National Institutes of Health (NIH)
• Office of the Inspector General (OIG)
• Substance Abuse and Mental Health Services Administration (SAMHSA)
• American Heart Association
• American Cancer Society
• Arthritis Foundation
• Susan G. Komen Foundation
• Alliance for Lupus Research

What does the supervisor's signature indicate?

"Supervisor Review Completed" 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, specifically as it relates to conflicts of time.

What is the difference between the State of Kansas Statement of Substantial Interests and Board of Regents 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.

In 2006, the Kansas Legislature approved a change in the scope of state employees required to file the KS SSI. As a result, many KU faculty were required to file the statement for the first time in the spring of 2006. These are two separate reporting requirements. Having filed a KS SSI does not change faculty or staff obligation to file a COI declaration at least annually.