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Institutional conflict of interest policy

Institutional Equity Disclosure form

Introduction

The University of Kansas encourages the development of new technologies that advance scientific knowledge and contribute to the public good. Researchers are encouraged to participate in technology transfer activities including forming new start-up companies based on newly discovered technologies. The Research Foundation, as licensing agent of the University of Kansas, may take an equity position in the start-up company when licensing a new technology to the start-up company. The purpose of this policy is to mitigate institutional conflicts (at each Research Foundation and the University) and to avoid the creation of other personal conflicts with regard to a Research Foundation's equity holdings. Various conflict of interest may arise when the University of Kansas Center for Research, Inc., or the University of Kansas Medical Center Research Institute, Inc., (each individually "Research Foundation") holds equity in companies that license technology and/or support ongoing research at the University of Kansas (University). The Lawrence campus (KULC) and the Medical Center campus (KUMC) of the University of Kansas each have a conflict of interest committee (each individually "Conflict of Interest Committee") for overseeing and managing the conflict of interest for the respective campuses. This policy concerns conflict of interest other than personal conflict of interest that may arise when a faculty member or other employee stands to benefit financially from the results of his/her own research. The University has policies in place to deal with these conflicts. Basically, these personal conflicts are managed by requiring disclosure to the Chairperson/Director, Dean/Vice Chancellor, a Conflict of Interest Committee, and the Vice Provost for Research and Graduate Studies/Provost as appropriate. A management plan for personal conflicts is developed through a Conflict of Interest Committee and approved of by the Vice Provost for Research and Graduate Studies/Provost.

An institutional conflict may develop when the institution (such as a department, center or college, the applicable Research Foundation, or the University) stands to benefit financially from the outcome of research ongoing at the University to support a license or a research agreement. A Research Foundation, and/or units at the University, along with inventors, may receive future financial rewards by way of royalties or other fees if the product or service is commercially successful. Therefore, they have a financial interest in ensuring the success of the product. If the returns are in the form of royalties, there is a control, however. The market must buy the product or service and will judge it on its merits, not on earlier university actions. Otherwise, there are no royalties.

A Research Foundation may hold equity in licensees, most often equity taken in lieu of royalties or other license fees. In these instances the potential institutional conflicts become more likely for several reasons:

  1. Equity markets are not perfect. Speculators reacting to information such as research results may cause substantial changes in market value. This may occur before any product sales.
  2. Unlike royalties, owners of equity may cash in their shares prior to the product or service passing the market test of generating sales. This creates a situation where a Research Foundation and the inventor may enhance their positions relative to other shareholders by having superior or "insider" information.
  3. A Research Foundation generally accepts a level of equity that could have substantial value if the product or service is successful. Therefore, the size of the transaction makes the potential institutional conflict even more serious.
  4. The University and a Research Foundation, as well as the inventor, must avoid even the appearance of manipulating stock prices through issuing or using information that may later prove incorrect, such as promoting a drug discovery that later fails testing mandated by regulatory agencies. Such manipulation exposes these entities and individuals to significant criminal and civil liabilities.

Acceptance of equity in licensees of university technologies is within the overall mission of each Research Foundation. There are two compelling reasons:

  1. Many technologies are best developed within a small entrepreneurial company. In such cases, cash held by these companies may be better employed in product development and marketing rather than paying a cash license fee.
  2. The development of technologies in a small company may enhance economic develop-ment within the region, which is also of benefit to the University and the State of Kansas. By licensing to new companies that locate within the region, jobs are created. If the company is successful, many jobs may be created.

Hypothetical Situation:

To illustrate the issues involved in institutional conflicts of interest, consider the following hypothetical case. A Research Foundation licenses a drug developed at the University to a start-up biotechnology company (BIO). As an alternative to a license fee, a Research Foundation takes 100,000 shares of BIO stock that is 10% of the founders' shares. The stock has no market value initially and is carried on the books at a value of zero. Suppose that after the license agreement is entered into, the entrepreneur is successful in a private placement and raises $5,000,000 for future research and development from venture capitalists at a price of $4 per share. Thus, a Research Foundation position has now effectively grown to $400,000 although there is no market for the stock. The venture capitalists that invested in BIO anticipate that if the drug goes through clinical trials, it will create a valuation at 20 times their investment. Thus, a Research Foundation looks at a potential stock price at a public offering of $80. A Research Foundation's position would then be worth $8,000,000. Under current policy, a Research Foundation would sell the stock as soon as practicable when it becomes publicly traded. The revenues would be distributed to the inventor, the researcher's department or center, and a Research Foundation according to University policy. Additionally, if the stock reaches this value, it is likely that there will be many millions in royalty income over the life of the patent. These funds will also accrue to the inventor, the department or center, and a Research Foundation.

With a potential $6 million from the sale of stock, plus future royalties coming to the University, there is a large incentive for units to make this technology successful. Developmental research may be the key to success. This is widely known by the financial community that will become very interested in research progress reports. If research continues on the invention at the institution, and particularly if that research is partially or wholly conducted by the inventor, conflict of interest or the appearance of such conflicts may occur. (The following analysis is taken from the University Research Foundation Conflict of Interest Policy regarding Equity Holdings and borrows heavily from Ezekiel Emanuel and Daniel Steiner, "Institutional Conflict of Interest," The New England Journal of Medicine, January 26, 1995.)

Examples of situations in which such conflicts may lead to decisions not in the best interests of the University or a Research Foundation are:

  1. The inventor/researcher may elect to assign his/her graduate students to work on the project although this may not be in the best interests of the careers of the graduate students because of confidentiality reasons or simply the nature of the science or technology involved.
  2. The researcher may inappropriately divert resources from research not funded by the licensee company (i.e., supported by a federal agency or another corporate sponsor) to development of the invention.
  3. The department may assign excessive laboratory space or other resources to the project, crowding out more deserving science/technology in terms of research and educational value.
  4. The department/unit, the college, and the University will have an incentive to keep the researcher on the faculty/staff and involved with the technology. This may conflict with normal tenure, promotion, and merit pay standards. For the same reason, the researcher may be allowed to enter into inappropriate consulting or other agreements with the company.
  5. If future research involves clinical trials, there may be pressure on the institution to aggressively seek patients for these tests, to fail to inform patients of the potential conflict, and to ignore or minimize symptoms that suggest an adverse reaction to the drug.
  6. There is a risk that the researcher will employ a research design or data collection that biases the study to obtain the desired results and that traditional institutional checks on the behavior will be ignored.
  7. In reporting the results to the public or in other public relations activities, the University and the researcher have an incentive to portray research progress and the potential for the company in the best possible light to maximize investor interest in the company.
  8. If another researcher at the institution invents an alternate therapy or product, which may be more efficacious for the patient or have more value for consumers, the University may not pursue further development or licensing because of economic competition with the existing invention.

Policy:

The University encourages and supports the transfer of University-developed technology to commercial entities. Technology transfer is an important outcome of the University's research and educational efforts. To ensure that the mission of the University is not compromised and that research integrity and objectivity is held to the highest standards, the University of Kansas, the University of Kansas Center for Research and the University of Kansas Medical Center Research Institute have adopted the following policy to deal with the potential and actual conflicts created when a Research Foundation holds equity interests in commercial enterprises that license technology and/or support ongoing research at the University:

  1. Disclosure and Responsibility for Monitoring:
    1. Any material provided to the public, to scientific journals, or to professional organizations from the University, a Research Foundation, or from their respective employees shall include the disclosure that the University, a Research Foundation, and/or the inventor(s) have financial interests in the licensing company. The person providing the material is responsible for making such disclosures.
    2. When a Research Foundation takes an equity interest in a company, the President of a Research Foundation shall file an Equity Disclosure Form with a Conflict of Interest Committee through the Director of Research Administration (or appropriate officer responsible for oversight of the Conflict of Interest process). The Equity Disclosure Form shall be signed by the President of a Research Foundation and the Provost of the University. Copies of the form shall be distributed to the appropriate department chair or director, and dean or vice chancellor and the Vice Provost for Research and Graduate Studies at KULC and the appropriate Vice Chancellor at KUMC.
    3. When a research contract or grant is entered into by the University or a Research Foundation with a company in which a Research Foundation holds an equity interest, or when a research project is commenced dealing with a licensed product of a company in which a Research Foundation holds an equity interest, the Director of Research shall inform the appropriate officials of the potential conflict of interest of any faculty member or other employee ("Researcher") working on that research project. Notification shall be made to the department chair or director, to the dean of the college or appropriate vice chancellor, and to the Vice Provost for Research and Graduate Studies. The dean of the college or appropriate Vice Chancellor or Vice Provost, with oversight by a Conflict of Interest Committee on behalf of the Provost, shall be responsible for monitoring the situation through a management plan, with special attention to resource allocation, employment practices, and graduate student assignments, and for informing the Researcher of this policy. At the discretion of a Conflict of Interest Committee, certain cases (such as the BIO example) where the potential conflicts are significant, the college dean or appropriate vice chancellor shall make annual written reports to the University's General Counsel's office, which will assist these persons in overseeing the disclosure and management of potential conflicts. A copy of the reports shall also be sent to the Provost's office. In all cases in which a Research Foundation has an ownership interest, any proposed changes in the license or research agreements involved or any potential sale of that interest shall be immediately reported to the General Counsel's office.
    4. The financial interests of the University, a Research Foundation, and the Researcher must be disclosed in writing to any human research subject by a Research Foundation through the appropriate Institutional Review Board.
  2. Research:
    1. Any clinical trials/product testing of University licensed technology shall be disclosed to and managed by a Conflict of Interest Committee.
    2. Any research involving University-licensed technology shall be designed to avoid any conflict of interest or the appearance of a conflict of interest in order to achieve maximum validity and reliability of the researcher's results and interpretation of results. The Researcher shall keep extensive notes to detail results and other issues that came up during the study.
  3. Equity Decisions:
    1. Research Foundation managers, including directors and officers, shall not acquire an equity position in any commercial enterprise that has provided the Research Foundation an equity position as consideration under a license or other agreement. Additionally, Research Foundation managers shall not acquire an equity position in any commercial enterprise in which a Research Foundation has otherwise acquired an equity interest. A list of such equity positions shall be found in each Research Foundation's annual audit.
    2. University department chairs, directors, deans, and vice chancellors (including associate and assistant administrators) shall not acquire an equity position in any such company when the respective department, center, school or college may benefit financially from a license of University owned technology to the company or other agreement with the company. This restriction shall not prevent such university officials from acquiring equity positions in start-up companies licensing university technologies when they are an inventor/creator of the technology licensed to such company.
    3. Each Research Foundation shall divest its equity position as soon as feasible. Such a sale will be accomplished upon the advice of a Research Foundation's Investment Subcommittee and a Research Foundation's investment manager.
    4. The prohibition on the acquisition of an equity position by individuals described in this section shall apply equally to immediate family members and members of those individuals' household as well.

Questions? Please contact:
William Sharp
785-864-7430 | wsharp@ku.edu
Director | Research Integrity

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Susan MacNally
785-864-4148 | sumac@ku.edu
Compliance Coordinator | Research Integrity