Issued: May 13, 2000
Owner: Director of Sponsored Programs
RESOLUTION OF CONFLICTS OF INTEREST AS THEY
RELATE TO RESEARCH CONTRACTS
This policy describes the general guidelines for resolving conflicts of interest as they relate to section five of the goldenrod Proposal Approval Sheet (SP-10) - to declared conflicts of interest, and not to hidden or undisclosed conflicts.
2.0 Policy [Top]
Principle Investigators should disclose any financial interests (including those involving the Investigator’s spouse, dependent children and other household members) that would reasonably appear to be affected by research or educational activities funded or proposed for funding by an external agency, or any interest in entities whose financial interests would reasonably appear to be directly and significantly affected by such activities.
Financial interests are defined as follows:
- Ownership or liability (assumed or incurred) that exceeds 3% of the total equity of the Company;
- Annual income, salary, other compensation, fringe benefits, or benefits from the use of property, or any combination thereof, paid or provided by the Company that exceeds, or may reasonably be anticipated to exceed $10,000 annually;
- Ownership of real or personal property used by the Company if the interest exceeds $10,000 in value. This interest excludes ownership in a business, income, salary, other compensation, fringe benefits or benefits from the use of property. Thus, these items are not added to the interest; only where the interest or ownership alone exceeds $10,000 in value is a financial interest established.
A financial interest (as defined above) is an involvement in any company or organization other than the sponsoring organization that might reasonably appear to be affected by the proposed research.
2.2 Exemption Clause
An employee’s receiving consulting or other income of over $10,000 per year from a firm that contracts with the University will not create a conflict of interest if the employee and members of his immediate family do not participate and have no authority to participate in the negotiation of the contract on behalf of the firm, and the employee either has no authority to or disqualifies himself from participating in negotiating the contract on behalf of the University.
2.3 Procedure for Reviewing and Resolving Conflict of Interest Issues
The process of reviewing conflict of interest situations within the University system is as follows:
1. If a Principal Investigator acknowledges a possible conflict of interest, by answering “Yes” to question 5 on the goldenrod proposal approval sheet (SP-10), he/she should immediately disclose the potential conflict in a letter to his/her Department Chair, fill out a Statement of Economic Interests, and send it to the Assistant Vice President for Finance.
Possible Exemption: If the possible conflict involves consulting or other income of over $10,000 per year from a firm that contracts with the University, the employee will not create a conflict of interest if the employee and members of his immediate family do not participate and have no authority to participate in the negotiation of the contract on behalf of the firm, and the employee either has not authority to or disqualifies himself from participating in negotiating the contract on behalf of the University. If applicable, the employee should document these facts in a letter to the University Comptroller and attach the letter to the Statement of Economic Interests.
2. If the Chair considers the project worthwhile, the proposal, letter of non-participation (as described above in the possible exemption section), if applicable, and a letter of approval are forwarded to the Dean.
At the same time, the school research administrator assigns a title to the conflict and sends it to his/her Vice President and Provost, in preparation for the subsequent docket review. The school research administrator also immediately prepares a resolution and sends it to the Office of the General Counsel for consultation, along with the following review materials:
- Copy of the research proposal
- Letter from the P.I. to his/her Department Chair disclosing the financial interest
- Terms of the contract (meeting University policies and procedures)
- Disclosure of any other conflicts of interest, and of any other financial arrangements (i.e., income or equity) which should be disclosed. This should include arrangements with students, and any members of the P.I.’s laboratories who are also household members of the P.I.
- Names of those negotiating the contract, both for the University and for the Company
- Date of incorporation, location and liability of the Company
3. After the General Counsel’s Office has given its advice, review materials are forwarded as follows, depending on where the conflict of interest originates:
Conflicts of interest in the School of Medicine: The Dean (or an appointed representative) forwards the review materials to the Vice President and Provost for Health Sciences, and to the Vice President for Research and Public Service for review. The Office of the General Counsel consults throughout on developments in the review and resolution process.
Conflicts of interest outside the School of Medicine: The appropriate Dean (or an appointed representative) forwards review materials to the Vice President and Provost of the University, and to the Vice President for Research and Public Service for Review. The Office of the General Counsel consults throughout on developments in the review and resolution process.
4. Docket Review and Board of Visitors Committees: At the point where materials have been reviewed and resolved to the satisfaction of the above parties, final resolution materials are forwarded to the Executive Vice President and Chief Operating Officer. After the Executive Vice President reviews the resolution for its potential economic impact on the University consents, the materials are ready for Docket Review. This meeting is attended by the Rector, the President of the University, the Executive Vice President and the Vice Presidents. Thereafter the procedure is as follows:
a. Six weeks before the Board meeting--Preliminary docket meeting. No documentation is required, but the Vice President who will propose a resolution must have general information about the situation to present. At this meeting, items are reviewed and preliminary decisions are made about which items should be on the meeting agenda.
b. One month before the Board meeting--main docket review. Documentation including a draft resolution should be sent to the Board office five (5) days in advance of the meeting. This should go through the appropriate V.P. to the Board office.
c. Two weeks before Board meeting--final docket review. All items are reviewed by the Rector, President and Vice Presidents. All resolutions and documentation should be complete and in final draft form.
d. Board meeting: A research conflicts resolution goes to either the Educational Policy Committee or the Health Affairs Committee. Peter Low leads the former, while Dr. Cantrell leads the latter. These items would normally appear on the consent agenda, unless an item is particularly controversial. If the Committee approves the resolution, it is officially voted on by the full Board at the end of the Board meeting.
Note--Executive Committee Meetings of the Board of Visitors:
In the case of emergency, items can be scheduled on the agenda of an Executive Committee Meeting of the Board of Visitors. However, conflict of interest items should only generally be coupled with other items for which an Executive Committee Meeting has already been convened. Items which need speedy resolution (e.g., SBIR/STTR’s) are generally candidates for the agenda of an Executive Committee Meeting. Executive Committee Meetings tend to take place four or five times per year, to accompany the four to five regularly scheduled meetings of the full Board of Visitors.
3.0 Definitions [Top]
Conflict of Interest Definitions: Employees of the State of Virginia may negotiate only one employment contract with the State of Virginia, which is usually their employment with the University of Virginia. If another contract were contemplated, through a sub-contract or familial relationship, for example, then this could constitute a conflict of interest. Contracts which might lead to these conflicts are not typically permitted. However, when the contract involves research and development (or in certain specific cases, commercialization of University intellectual property), the Board of Visitors may grant an exemption.
4.0 References [Top]
5.0 Approvals and Revisions [Top]