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Guidance to Principal Investigators for Disclosure and Review of Financial Interest in Non-Governmental Sponsors of Research

• Background
• Definitions
• General Principles
• Guidance to Principal Investigator
• Committee Recommendations
• Principal Investigator and Department Chair Responsibilities

Background

The purpose of this summary is to raise the awareness of the Irvine campus community to the University's conflict of interest policy and to specific concerns regarding the sponsor-investigator relationship in the design, conduct, or reporting of research. The document also provides guidance to principal investigators on the review process when they have disclosed financial interests in a non-governmental sponsor of research.

The University is tasked by the State of California with specific responsibilities under the State's Political Reform Act. The Act requires disclosure of financial interest(s) in a non-governmental sponsor of research if the support equals $250 or more. University policy provides both a mechanism and a process for this disclosure. Principal investigators need to disclose their interests at the time an application is made for funding, when new or additional funding is received, and at the conclusion of the award period. A review is conducted by the Conflict of Interest Oversight Committee (COIOC) of those disclosures in which the Principal Investigator has a financial interest in the sponsor. The Committee is advisory to the Vice Chancellor for Research and makes a recommendation to him/her for acceptance, acceptance with conditions, or disapproval of the gift, grant or contract based on review of the information provided.

More complete information can be found in the following documents:

• Academic Personnel Manual, Section APM-028-0, "University Policy on Disclosure of Financial Interest in Private Sponsors of Research," April 26, 1984.
• Academic Personnel Manual, Section APM-028-10, "Guidelines for Disclosure and Review of Principal Investigator's Financial Interest in Private Sponsors of Research," April 27, 1984.
• UCI Policy and Procedures Manual, Section 700-12, "Compendium of Specialized University Policies, Guidelines, and Regulations Related to Conflict of Interest," revised August 1, 1989.

Definitions

1. Financial Disclosure: The Statement of Economic Interests is to be completed by the Principal Investigator and any Co-Principal Investigators for all research projects which have been or will be funded, in whole or in part (1) through a contract or grant of $250 or more by a non-governmental entity; or (2) by a gift from a non-governmental entity which is earmarked by the donor for a specific research project or a specific principal investigator provided the amount of the gift, or the aggregate over a 12 month period, from the same donor is $250 or more. (APM 028)
2. Financial Interest: Under California law, a financial interest in the sponsor means: a direct or indirect investment in the sponsor or any stock options or warrants whose value is $2,000 or more; a position as director, officer, partner, trustee, employee of or any other position of management in the sponsor; income from the sponsor, including consulting income aggregating $500 or more in value, or $50 if the income was a gift, received by or promised to the principal investigator within 12 months prior to the time the award is made; ownership directly, indirectly or beneficially in any business entity or trust with a financial interest in sponsor greater than 10%; loans from sponsor/donor with balance exceeding $500 in past 12 months, or travel and related expenses paid for by sponsor/donor.
   
   A direct investment is one in which the principal investigator holds equity or receives income in his/her own name. An indirect investment is one where another person holds equity or receives income under circumstances that may accrue to the benefit of the principal investigator, for example, where the investigator's spouse or child(ren) hold the investment in their name(s). Disclosure of both investment types is required. In addition, a direct or indirect interest of 10% in a business entity or trust which has a financial interest in the sponsor of the research is considered a "financial interest." (APM-028)
3. Conflict of Interest: The term conflict of interest in research refers to situations in which financial or other personal considerations may compromise, or have the appearance of compromising, an investigator's professional judgment in conducting or reporting research. (AAMC, February 22, 1990)

General Principles

1. Principal Investigators, like all UC employees, are expected to separate their University and private interests.
2. The activity must benefit the University's mission of teaching, research, and public service.
3. The teaching and research environment should promote the free exchange of ideas, information, and materials among students and faculty.
4. There should be no limits on the freedom to publish, other than short delays allowing a sponsor to comment or to permit filing of patent applications by UC.
5. University resources must not be used without proper compensation.
6. Licensing agreements to a sponsoring firm in which the investigator has a financial interest require careful review to ensure that the best interests of the public and the University are served.

Guidance to Principal Investigator

Research for a sponsor in which the investigator has a direct or indirect financial stake can pose a conflict between interests which are related to the researcher's academic responsibilities, including processes whereby truth is made known, and those which may provide personal economic benefit.

Most disclosure cases are unique, requiring the Conflict of Interest Oversight Committee to evaluate an entire spectrum of interests. Assessment of the degree of conflict of interest depends on a number of other related factors, such as the amount of equity and income, consulting relationship, company product line, relationship to University research, and adherence to UC policies on amount of outside activities. The Committee assesses the unique, fact-specific circumstances to determine whether and, if so, how a conflict of interest can be managed.

The following discussion may help investigators structure a research relationship or make personal decisions concerning financial involvement which avoid a real or apparent conflict of interest.

1. Type and Breadth of Financial Interest: The type and breadth of the investigator's financial interest(s) affect consideration of a conflict of interest situation. For example, income from lectures or a seminar presentation, or sometimes consulting, appear less likely to influence a situation than an investment or income taken in the form of a stock option. Holding a position on a scientific advisory board is generally seen as creating a harmful conflict of interest situation only when the individual fails to absent himself/herself from the final discussion and decision to fund his/her own research. Holding any other position of management, such as an officer of the corporation, can place an individual in an unmanageable conflict of interest situation due to clear obligations to both the sponsor and the institution. A combination of these interests may increase the Committee's concern regarding the investigator's involvement in the sponsor's activity and his/her ability to separate responsibilities.
2. Amount of Financial Interest: Generally, the larger the amount of the investigator's equity interest, the greater the opportunity for financial gain and the greater the potential for conflict of interest. Therefore, the Committee considers the size of the sponsor (outstanding shares of stock), whether the stock is publicly or privately traded, the relative level of investigator equity, and the diversity of company interests. Usually, the larger the company and the lower the relative investigator equity, the less the concern that the investigator would be in a position to affect the stock value or other financial interests. Similarly, a larger and more successful corporate portfolio would diminish concerns for the influence of one research project at the University.
   
   The amount of consulting income and the existence of a long-term consulting agreement may also heighten the potential for a conflict of interest. Continuation of this stream of income may lead to potential, albeit unconscious, bias in the research being conducted. Conflict of commitment may also become a related concern.
3. Support History: Current funding and the funding history of the investigator are additional variables considered by the Committee. A broad base of research sponsorship may minimize the influence of one sponsor on the research and thus the potential risk for a conflict of interest. In addition, the use of the sponsor's pending support, and information regarding the frequency and amount of previous awards from the sponsor, help the Committee evaluate the potential for a conflict of interest in the specific situation under review.
4. Clinical Trials Research: Clinical trials research creates special concerns when performed by an investigator having a financial interest in the sponsor or manufacturer of the drug, device or product being tested. Of particular interest to the University is that human subjects may be placed at additional risk because of the investigator's financial interests. The COIOC cooperates with the Institutional Review Boards to provide review of conflict of interest issues on human subject protocols. The COIOC discourages principal investigators from doing clinical testing of their own inventions, and also suggests researchers structure the study to alleviate conflict of interest concerns. Multi-center, blinded, randomized, prospective trials minimize the ability of one investigator to control the study results in order to obtain personal financial gain. Therefore, the COIOC reviewers consider whether one or a combination of the above design criteria is sufficient to prevent a harmful conflict of interest situation.
   
   Principal investigators are reminded to advise subjects through the informed consent form of any interest the physician or practitioner has in the sponsor or the company providing the test drugs or devices, even if these materials were provided without cost. Provision of this information discloses the conflict of interest to the individual most affected by the research activity - the human subject.

Committee Recommendations

The review and recommendation process can be a complex one where the potential and/or perception of a conflict of interest must be carefully considered. In conduct of its duties, the Conflict of Interest Oversight Committee weighs both the beneficial opportunities for research progress through the award of funds from non-governmental sponsors and the potential for investigator conflict of interest. The Committee's decisions attempt to apply the stated policy guidelines equitably across all academic disciplines and activities.

The COIOC will consider the research project according to traditionally held principles of ethical conduct and academic freedom. The COIOC will evaluate whether: there is sufficient separation of University and private interests, the proposed research is appropriate to the University, the teaching and research environment is open, freedom to publish and to disseminate research results is preserved, the University's rights are protected, the University's facilities and resources are used appropriately, and that the University receives proper compensation for their use.

For clinical trials, the COIOC must consider the effect of the disclosed financial interests on the rights and welfare of the human subjects participants. The COIOC must consider whether the rights of the participants would be better protected by reduction or disclosure of a financial interest, separation of responsibilities for financial and research decisions, additional oversight, elimination of a financial interest, implementation of an independent data and monitoring committee, modification of roles in research staff, or any other mechanism which would mitigate effects of the financial interest.

The Committee examines the Statement of Economic Interests form, the supplemental addendum, additional documents provided by the investigator, and other relevant materials. Additional information may be requested by the Committee. Provision of full and complete information significantly aids the Committee in its review and recommendation to assure objectivity in research.

The following general recommendations are given to provide guidance on what kinds of interests are viewed as potentially harmful, requiring management, reduction, or elimination.

• A PI who is also the president or CEO (or otherwise involved in the day-to-day operations) of a for-profit sponsor is generally considered to have an unacceptable conflict of interest which must be reduced in order for the conflict to be manageable.
• A PI who also holds a position, other than day-to-day management, with a for-profit sponsor is considered to have a conflict of interest that the University may be able to manage. (See Section IV.A. for additional guidance.)
• Clinical trials on a drug, device, or patented procedure developed by the faculty/researcher are generally considered unacceptable.
• Sponsored research on the PI's own intellectual property not involving human research subjects is a conflict of interest which the University may be able to manage.
• Equity (ownership) interest in a sponsor is a particular concern because it can create a unique, and potentially unmanageable, tension for the investigator who must balance his/her academic research interests with the goals and/or expectations of the research sponsor. (See Section IV.B for more discussion of the range of considerations.)

The Committee's recommendation to the Vice Chancellor for Research is advisory and may offer suggestions for mechanisms to manage a conflict. These options may include public disclosure of the financial interest; appointment of a third party to monitor and report periodically; oversight by an ad hoc panel; modification of the research plan; disqualification from participation in all or a portion of the project; divestiture of the financial interest; or severance of relationships that create actual or potential conflicts. The final decision for approval or disapproval rests with the Vice Chancellor.

Principal Investigator and Department Chair Responsibilities

1. To Disclose: Failure to file a complete Statement of Economic Interest (and Addendum, when necessary) or to comply with conditions or restrictions imposed on the conduct of the project under University policy will be referred to a Regulatory Non-Compliance Review and may affect the award process. There may also be grounds for discipline pursuant to the Policy on Faculty Conduct and the Administration of Discipline or other applicable employee disciplinary policies.
2. To Recuse: Department Chairs must disqualify themselves from approving a research proposal for a project to be funded in whole or in part by an entity in which they have a financial interest. They must refer the proposal to the next higher level of authority for review and approval.

 

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