Introduction and Rationale
These guidelines implement the UC policies on Disclosure of Financial Interest in Private Sponsors of Research (State) and Policy on Disclosure of Financial Interests and Management of Conflicts of Interest Related to Sponsored Projects (Federal)
University research is currently reviewed according to the principles specified below and to other well-established policies guiding the conduct of sponsored research, including the principle that researchers must be free to pursue knowledge and that this freedom, which is essential to the research process, must not lightly be abridged. The proposed review is supplemental to this process and takes advantage of the expertise and structure of the existing system. While it is normally the case that a principal investigator takes responsibility for the central issues raised in these guidelines, when a principal investigator has a financial interest of the sort defined in the University Conflict of Interest Code requiring disclosure, it is possible that his or her judgment may appear to be affected by potential financial gain rather than by the pursuit of knowledge. Therefore, it is proper that the principal investigator, the University community, and the public be assured that the principles central to the research process be followed.
Guiding Principles
A. Traditional conflict of interest situations should be avoided
In the conventional sense, conflict of interest refers to situations in which employees may have the opportunity to influence the University's business decisions in ways that could lead to personal gain or give advantage to associates or firms in which employees have an interest. Employees are expected to separate their University and private interests in accordance with existing University policies, State law, and Federal regulations.
B. Project is appropriate to the University
The project must be appropriate to the mission of the University, i.e., promising significant contributions to scholarship and knowledge and, when possible, providing appropriate opportunities for students.
C. The teaching and research environment is open
The teaching and research environment should continue to promote the free exchange of ideas, information, and materials among students and faculty in all of their forums—classrooms, laboratories, meetings, and anywhere in the University. Selection of students for participation in the research project should not be inappropriately influenced by private interests.
D. Freedom to publish and to disseminate research results is preserved
Consistent with current University policies, there should be no limits placed on the freedom to publish, except for short periods of delay that permit a sponsor to comment or to permit filing of patent applications. Unpublished research findings should be made available on a nondiscriminatory basis and should not favor an entity in which there is financial interest.
E. University facilities and resources are used appropriately
As is currently the policy, University resources—supplies, equipment, and facilities, as well as staff time—must not be used for the benefit of private interests without proper compensation to the University.
F. Does the financial interest reasonably appear to have a direct and significant affect on the project
Direct affect is when the project results would be directly relevant to the development, manufacturing, or improvement of products or services of the business entity
Significant impact materially affects the value of the organization, its earnings, or the sales of its products (or it is a proposed subcontractor or participant in the federally funded project)
CONDUCT OF REVIEW
(Note: The term "entity" means any business or commercial entity in which the disclosing person {"principal investigator"} has a financial interest; this "entity" may be the sponsor of the project under review or a business which commercializes products or services related to the project.)
A. Assure adherence to relevant University policies, guidelines, and regulations
These policies are identified, summarized, and paraphrased in the Compendium of Specialized University Policies, Guidelines, and Regulations Related to Conflict of Interest (Rev. 4/15/86) and "Policy on Disclosure of Financial Interests Related to Sponsored Projects" (10/97).
B. Consider, to the extent possible, the nature and extent of the financial interest in the entity
Consider the potential financial effects of the research on the principal investigator, the investigator's related financial interests, and the sponsor.
C. Give special consideration to:
- Conditions of research agreements which involve:
- The testing products or inventions
- Research conducted in the entity's facilities
- Research performed jointly with someone from the entity
- Research involving the provision of proprietary information from the entity
- The relationship between the principal investigator and the entity when the principal investigator has:
- A significant ownership interest in the entity
- The opportunity to receive substantial financial benefits from the entity (e.g., bonuses, stock options)
- A long-term or ongoing consulting relationship with the entity
Review Committees may find it useful to get more information from the principal investigator than is covered in the financial disclosure statement. This additional information is subject to disclosure as a public record, as is the disclosure form.
E. Some questions which might be considered when appropriate are:
- Do the facts and circumstances suggest that the principal investigator's financial involvement with the entity will in any way affect or impair the conduct of the research in accordance with the applicable policies and the highest professional standards?
- How will the interests of the University be maintained in consideration of the principal investigator's interest in the entity?
- Will the research project lead to the advancement of knowledge rather than to routine testing of primary benefit to the entity?
- How will this research project contribute to the University's mission of teaching, research, and public service?
- Do the potential public benefits to be gained from undertaking this research outweigh any potential erosion of academic freedom, collegiality, or public trust?
When reviewing financial interest disclosures, the following issues should be considered in order to determine the level of conflict and the value of the research project. This list is not intended to be all inclusive.
Conflict of interest is within acceptable guidelines
- Ownership interest in sponsor or outside entity is not significant
- Consulting is within guidelines for outside activities
- Consulting is in an area separate from the research project
- Personal consulting agreement terms do not interfere with University obligations
- The PI does not stand to benefit financially by the conduct or outcome of this project
- No product or testing of a product is involved in the project
- Project appears to support research leading to advancement of knowledge
- Project provides appropriate research activity for students or post-doctoral researchers, and their academic and scholarly interests can be maintained
- Will the research plan receive independent peer review prior to its initiation? If so, by whom and does this lessen potential conflicts?
- The project provides appropriate research activity for students, and students' best interests can be maintained
- No restrictions on the free exchange of ideas, information or materials are apparent
- Personnel of sponsor or outside entity will collaborate in the project, but their involvement will not interfere with the appropriate openness of the project
- If any proprietary information of sponsor or outside entity is provided, restrictions on disclosure of use of such information will not interfere with openness of the research nor dissemination of results
- Are there adequate mechanisms in place to prevent the introduction of bias into the project? Are there means provided or available to independent verification of research results?
- There are no restrictions on the free exchange of ideas, information, or materials
- Personnel of sponsor or outside entity will collaborate in the project, but their involvement will not interfere with the dissemination of results of the project
- If any proprietary information of sponsor or outside entity is provided, restrictions on disclosure of use of such information will not interfere with openness of the research nor dissemination of results
- Will the results be shared openly with independent researchers and published in peer-reviewed journals?
- Proposed budget includes appropriate reimbursement of University costs
- Any proposed University cost sharing is consistent with policy and does not favor the sponsor or any outside entity
- Proposed mechanisms of technology transfer of inventions and copyrights are appropriate
- There is no conflict between University patent and copyright policy and the terms of any consulting or other agreement with the sponsor or outside entity
When reviewing financial interest disclosures, the following issues should be considered in order to determine the level of conflict and the value of the research project. This list is not intended to be all inclusive.
Management or elimination of conflicts of interest may include but are not limited to:
- Withdrawal of proposal
- Non-acceptance of the gift or grant
- Notice to students and other project personnel of Investigator's conflicting interests
- Appointment of additional, non-conflicted student advisors
- Public disclosure of the related financial interest
- Monitoring of the project by independent reviewers
- Modification of the research or project plan
- Disqualification from participation in all or a portion of the project
- Divestiture of the related financial interest(s)
- Severance of relationships that create actual or potential conflicts
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