University Responsibility

The Office of the Vice President for Research, including the Office of Sponsored Programs (OSP) and the Office of Technology Transfer (OTT), is responsible for implementing Policy 4001. This responsibility includes providing advice and technical assistance to employees in the preparation of requests for waivers of conflicts of interests in contracts between the University and businesses for research and development or for the commercialization of intellectual property (collectively referred to in this Procedure as “research or commercialization contracts”).

Employee Consultation and Disclosure

Employees who may have a potential conflict of interests in research or commercialization contracts are encouraged to consult with their immediate supervisors and the Office of the Vice President for Research on conflicts of interests as early as possible. If an employee has a potential conflict, it may be possible to prevent it. If a conflict cannot be prevented, it may be possible to ameliorate or manage it to allow the University to approve a waiver of the conflict. Early consultation facilitates the timely consideration of these possibilities.

In addition, an employee may seek an opinion from the Attorney General, who is authorized to render advisory opinions as to whether the facts in a particular case would constitute a violation of law. If the Attorney General determines that no conflict exists, the employee cannot be prosecuted for a knowing violation of the conflict of interests law. Employees who are considering seeking an Attorney General opinion are encouraged to consult with the Vice President for Research.

If an employee believes he or she may have a personal interest in a proposed contract for research and development that might give rise to a conflict of interests, the employee must disclose the potential conflict to his or her immediate supervisors and to the Office of Sponsored Programs in writing as early as possible and no later than the University’s submission of the contract proposal. Similarly, in the case of a contract between the University and a business for the commercialization of intellectual property, an employee who believes he or she may have a personal interest in the contract that might give rise to a conflict of interests must disclose the potential conflict to his or her supervisors and to the Office of Technology Transfer in writing upon learning that the University is negotiating with the business.

Remedies for Potential Conflicts

Conflicts of interests may be prevented, and certain conflicts may be waived. If the potential conflict arises solely from the employee’s having more than $10,000 annual income from a business and the employee does not have a personal interest in a proposed research or commercialization contract, the employee can prevent the conflict by not participating in the business’s contracting process and having no authority to do so (and, in the case of an employee who has authority to participate in the University’s contracting process, publicly disqualifying himself or herself from doing so). In such a case, the employee must submit a letter to the Office of Sponsored Programs stating that he or she meets the requirements for this exception.

In the case of a potential conflict involving a proposed research or commercialization contract, it may be possible to prevent the conflict through the divestiture of financial interests, severance of the relationship that would create the conflict, or delegation of financial interests to trust. Employees who have questions about conflicts of interests may consult the statute or seek legal counsel. The University’s Legal Affairs Department is not authorized to provide personal legal counsel to University employees.

Waiver Process

An employee who has a personal interest in a proposed research or commercialization contract that might give rise to a conflict of interests may seek a waiver from the President. In developing the waiver request, the employee should consult with his or her Center Director, Department head, and Dean or Director and, for a research contract, the Office of Sponsored Programs or, for a commercialization contract, the Office of Technology Transfer.. A request for a waiver describes the conflict and how it would be managed.

A request for a waiver must include each of the following pieces of information:

1. A summary of the activities to be carried out under the contract (not to exceed 100 words).
2. The name and a brief description of the business that would contract with the University (not to exceed 100 words).
3. The nature and extent of the employee’s “personal interest” in the contract. (See the Definitions section of Policy 4001.)
4. Any steps that have been taken or are proposed to be taken to manage the conflict of interests, such as --
· Monitoring of the activities under the contract by independent reviewers;
· Modification of the activities under the contract; and
· Disqualification of the employee from participation in certain activities under the contract.
5. The benefits that the University or the community would derive from the contractual relationship.
6. Any possible adverse effects of the contractual relationship for the University or the community.
7. The consequences to the University and the community of not granting the waiver.
8. The proposed time period of the waiver, not less than the period of the research and development contract or the agreement for the commercialization of intellectual property, as applicable.
9. An assurance that any intellectual property developed by the employee under the contract will be owned by the University.
10. An assurance that work performed by the employee under the contract will not be work for which he or she is compensated by the University.

In addition, the employee must complete an initial Statement of Economic Interests under Va. Code, § 2.2-3106.C.7.(ii) and provide it to the Vice President for Research in a sealed envelope.

A request for a waiver must be signed by the requesting employee. To be recommended for approval, the request must also be signed by the employee’s Center Director, Department head, and Dean or Director and by the Vice President for Research. The signature of each of these reviewing officials reflects the official’s determination that approval of the requested waiver is in the best interests of the University.

The Vice President for Research determines whether, and on what conditions, a waiver of a conflict of interests should be recommended to the President and how the employee’s compliance with the conditions for the waiver will be ensured. For a waiver for a period exceeding one year, the Vice President may require that the employee periodically certify continued compliance with those conditions. The employee must agree to the terms of a recommended waiver before the recommendation is made. If a waiver is recommended, the Office of Sponsored Programs prepares, and the Vice President transmits, the recommendation for the President’s consideration. Until the President has approved a waiver, the University will not enter into a contract that would give rise to a conflict of interests.

If the President approves the waiver, the Vice President for Research sends a copy of the approved waiver to the requesting employee and each official who reviewed the request and provides the envelope containing the Statement of Economic Interests to the Office of the President for filing with the Secretary of the Commonwealth.

If the President approves a waiver, the Office of Sponsored Programs advises the employee of his or her obligations concerning the filing of Statements of Economic Interests under Va. Code, § 2.2-3106.C.7.(ii):
· The employee must file an initial Statement of Economic Interests promptly upon the approval of a waiver, and
· The employee must file a Statement of Economic Interests by January 15 of each year after the filing of the initial Statement until the earliest of the following occurs: (1) the termination of the contract for research and development, or the agreement for the commercialization of intellectual property, as applicable; (2) the termination of the employment relationship with the University; or (3) the termination of the financial benefit or liability that gave rise to the conflict. The Statement must be filed for each year or part thereof in which the conflict existed.

If the President disapproves the waiver, the Vice President for Research notifies the requesting employee, each official who approved the request, and the Office of Sponsored Programs and returns the envelope containing the Statement of Economic Interests unopened to the employee for whatever action the employee chooses.

Record disclosure and retention

A request for a waiver of a conflict of interests is a public document when it is recommended for approval and transmitted to the President for consideration. Disclosure of such a request is subject to applicable State and federal law.

The Office of Sponsored Programs maintains a record of actions taken during the review and approval of a waiver for a minimum of three years following the termination of the contract. If a contract is supported by a federal agency that requires a longer period for the retention of records relating to conflicting interests of investigators, the records may be maintained for that longer period. (See, for example, regulations of the Public Health Service, at 42 CFR 50.604 (e)).

Approved:

_________________________________
Vice President for Research

Date: August 19, 2005