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Management of Inventor Conflict of Interest

Effective April 17, 2002

POLICY

A formal plan to manage conflict of interest will be developed for each inventor by the Conflict of Interest Committee and the inventor, with concurrence by the Vice Chancellor for Research. This plan will be reviewed annually or updated earlier if deemed necessary.

BACKGROUND

Increasingly, universities are collaborating with industry as they seek to fulfill their research mission and deliver new technologies for public benefit. The Bayh-Dole Act of 1980 allows and encourages the realization of financial gain to individual researchers and institutions as a result of their partnerships with industry. However, undisclosed and unmanaged conflicts of interest created by these collaborations pose a significant risk to professional and public trust in research findings. Specific concerns about conflict of interest arise when faculty members take part in research on their own inventions. Ideally, researchers without conflicts of interest would be recruited to serve as principal investigators on studies of university-owned technologies. If circumstances justify an exception, then the safeguards outlined in this policy would strengthen data integrity and the welfare of research subjects.

PROCEDURES

The Conflict of Interest Committee will initiate development of a management plan in adherence to the following guidelines and practices.

  1. As early as practicable, a Principal Investigator (PI) without conflicts of interest will be recruited for research on technologies in which the inventor and/or the university hold a financial stake.
  2. When feasible, clinical trials utilizing university discoveries also will be conducted at other universities to minimize bias.
  3. If research under the inventor's direction does not potentially benefit the start-up company, then he/she is free to hold a seat on the company's Board of Directors. Research is considered to be under the inventor's direction if he/she is principal investigator, or if he/she is department chairman or dean of the individuals conducting the research.
  4. The Conflict of Interest Committee will determine which measures may be appropriate to ensure data integrity and protection of human subjects. Such measures may include the requirement of oversight by a Data and Safety Monitoring Board and/or periodic audits of the research by a disinterested party.
  5. The University recognizes that, at times, the inventor will be the only individual who is qualified to conduct research on the new technology. In those cases, the following practices will be employed to manage the potential conflict of interest:
    1. The inventor shall not serve on the company's Board of Directors.
    2. If the inventor wishes to continue serving as PI for such a research program and the inventor has a direct management role in the Sponsor, a plan shall be developed with the overseeing Conflict of Interest Committee and approved by the appropriate Vice Chancellor for Research for the inventor to transition out of the management role as soon as practicable. This plan shall include measures described in paragraph 4 above, including a Data and Safety Monitoring Board and/or periodic audits.
    3. The inventor may retain equity interests in the start-up company.
    4. The inventor may participate on the company's Scientific Advisory Board. Inventors shall recuse themselves from decisions by the Scientific Advisory Board, which involve their research.
  6. Within the University's academic departments, inventors may not make salary, promotion or tenure decisions for individuals who participate in research relating to a University of Kansas licensed technology where the inventor has a financial interest.
  7. Participation in the management of any company must comply with the Regent's policy on Conflict of Time Commitment.
  8. When a licensee or a sublicensee uses data to support product development by a company that has licensed University technology and/or in which the University has an equity interest, the Conflict of Interest Committee shall examine the relationship between the company and the licensee or sublicensee (research sponsor). The Committee will make a determination about whether a conflict of interest exists and, if it does, will ensure that an appropriate management plan is in place.
  9. The University of Kansas Medical Center Research Institute shall disclose the creation of new technology companies to the Conflict of Interest Committee so that planning for technology development and management of potential conflicts of interest can be jointly accomplished.

DEFINITIONS

Conflict of interest: A conflict of interest occurs when the divergence between an individual's personal relationships or interests and his/her professional obligations to the university is so close that an independent observer might reasonably question whether the individual's professional actions are determined by considerations of personal benefit, gain, or advantage.

Inventor: An inventor is an employee who has made independent, original, and conceptual contributions to an invention and to at least one of the eventual claims in the patent application. Requirements to disclose inventorship related to research also apply when the inventor is in the employee's "immediate family" (spouse and dependent children).

GROUPS COVERED

All faculty and unclassified staff members who invent a technology in their field of expertise while employed at the KUMC are subject to this policy.

RELATED POLICIES OR DOCUMENTS

Public Health Service regulations governing Conflict of Interest

Kansas Board of Regents Policy on Conflict of Interest - Section 13

Faculty and Unclassified Staff Handbook, Conflict of Interest Policy (PDF)

Annual Conflict of Interest Disclosure Form Contact the Research Administration

Invention Disclosure Form

Technology Transfer Revenue Distribution Policy

Institutional Conflict of Interest

Employment of Students and Residents in Faculty-Owned Businesses

CONTACT

Vice Chancellor for Research Administration, 588-5436

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