FINAL 10/1/04 WILKES UNIVERSITY CONFLICT OF INTEREST IN SPONSORED RESEARCH POLICY These guidelines define Wilkes University’s general policy and procedures regarding conflicts of interest in relationship to sponsored projects and sponsored research. The guidelines are responsive to requirements of the NSF (Section 510 of the Grants Policy Manual) and the Public Health Service (NIH GUIDE, Volume 24, Number 25, July 14, 1995). They are intended to protect the credibility and integrity of the University’s faculty and staff and to ensure compliance with Federal financial conflict of interest regulations. Wilkes University has no interest in interfering with faculty and staff in their pursuit of legitimate outside interests. The University does, however, have a responsibility to manage, reduce or eliminate any actual or potential conflicts of interest that may be presented by a financial interest of an investigator. The University therefore requires that investigators disclose any significant financial interest that may reasonably appear to be affected by sponsored projects. Definitions A potential conflict of interest occurs when there is a divergence between a person’s private interests and his or her professional obligations to Wilkes University such that an independent observer might reasonably question whether the person’s professional actions or decisions are determined by considerations of personal gain, financial or otherwise. For the purposes of this policy, a conflict of interest exists when the University, through procedures described herein, reasonably determines that a significant financial interest could directly and significantly affect the design, conduct, or reporting of sponsored projects. Investigator means the principal investigator/project director, co-principal investigators, and any other person who is responsible for the design, conduct, or reporting of research, educational, or service activities funded, or proposed for funding, by an external sponsor. In this context, the term "Investigator" includes the investigator's spouse and dependent children “Significant financial interest” means anything of monetary value, including, but not limited to: salary or other payments for services (e.g., consulting fees or honoraria) equity interests (e.g., stocks, stock options or other ownership interests) intellectual property rights (e.g., patents, copyrights and royalties from such rights). Specifically, a conflict of interest may occur when a faculty or staff member’s affilation with the external organization meets any one of the following criteria: 1. The faculty or staff member is an officer, director, partner, trustee, employee, advisory board member, or agent of an external organization or corporation either funding a sponsored project or providing goods and services under a sponsored project on which the faculty or staff member is participating in any capacity. 2. The faculty or staff member is the actual or beneficial owner of more than 5% of the voting stock or controlling interest of such an organization or corporation. 1 FINAL 10/1/04 3. The faculty or staff member has dealings with such organization or corporation from which he or she derives income of more than $10,000 per year, exclusive of dividends and interest. 4. The faculty or staff member’s immediate family (spouse and dependent children) meet any of the criteria stated in 1-3 above. The term “financial interest” does not include: 1. Salary, royalties, or other remuneration from Wilkes University; 2. Income from seminars, lectures, or teaching engagements sponsored by public or nonprofit entities; or 3. Income from service on advisory committees or review panels for public or nonprofit entities. Disclosure 1. Each Investigator is required to disclose the following significant financial interests: (i) Any significant financial interest of the Investigator that would reasonably appear to be affected by the research or educational activities funded, or proposed for funding, by an external sponsor; or (ii) Any significant financial interest of the Investigator in an entity whose financial interest would reasonably appear to be affected by the research or educational activities funded, or proposed for funding, by an external sponsor. Regardless of the above minimum requirements, a faculty or staff member, in his or her own best interest, may choose to disclose any other financial or related interest that could present an actual conflict of interest or be perceived to present a conflict of interest. Disclosure is a key factor in protecting one's reputation and career from potentially embarrassing or harmful allegations of misconduct. 2. Each Investigator who has a significant financial interest requiring disclosure shall complete a Significant Financial Interests Disclosure Form and attach all required supporting documentation. The completed Disclosure Form must be submitted to the office of the Director of Grant Support at least three days before the proposal submission date. Supporting documentation that identifies the business enterprise or entity involved and the nature and amount of the interest should be submitted in a sealed envelope marked confidential and accompany the Disclosure Form. This disclosure information will be forwarded to the Vice President for Finance and Support Operations for review. 3. If the proposal is funded, all financial disclosures must be updated by Investigators during the period of the award, either on an annual basis or as new reportable Significant Financial Interests are obtained. Review Process 1. The Wilkes University Vice President for Finance and Support Operations shall review all 2 FINAL 10/1/04 financial disclosures to determine whether a conflict of interest exists. A conflict of interest exists when the review reasonably determines that a significant financial interest could directly and significantly affect the design, conduct, or reporting of the proposed sponsored project. If the Vice President for Finance and Support Operations determines that there is a potential for conflict of interest covered by this policy, then the Vice President will convene the Conflict Review Committee to determine what conditions or restrictions, if any, should be imposed by the institution to manage actual or potential conflicts of interest arising from the disclosed significant financial interests. Members of the Conflict Review Committee will include the Vice President for Finance and Support Operations, the Director of Grant Support, and thethe Dean of the College or School where the individual under review holds a position. If the individual under review is a Dean, the Provost will appoint the third committee member. Following review of the disclosure materials, the Conflict Review Committee may impose conditions or restrictions, including the following: 1. 2. 3. 4. 5. 6. Public disclosure of significant financial interests; Monitoring of research by independent reviewers; Modification of the research plan; Disqualification from participation in all or a portion of the research funded; Divestiture of significant financial interests; or Severance of relationships that create actual or potential conflicts. The Conflict Review Committee may require that a plan for reducing or eliminating conflicts of interest be incorporated into a Memo of Understanding between Wilkes University and the Investigator. 3. The Vice President for Finance and Support Operations will notify the Provost of the conditions or restrictions to be imposed. If the Provost determines that imposing the above referenced conditions or restrictions would be ineffective or inequitable, or that the potential negative impacts that may arise from a significant financial interest are outweighed by interests of scientific progress, technology transfer, or the public health and welfare, then the Provost may recommend that, to the extent permitted by Federal regulations [PHS policy, for example, does not permit such an action], the research go forward without imposing such conditions or restrictions. The Provost may also consider faculty appeals to Conflict Review Committee’s decision(s). The Provost shall make the final decision regarding any resolutions that may be required regarding a proposed condition or restriction. Managing Conflicts of Interest Actual or potential conflicts of interest will be satisfactorily managed, reduced, or eliminated in accordance with these Guidelines and all required reports regarding the conflict of interest submitted to the sponsor prior to expenditure of any funds under an award. [For example, the PHS requires the University to report to the PHS Awarding Component the existence of a conflicting interest (but not the nature of the interest or other details) found by the University and assure that the interest has been managed, reduced or eliminated. NSF only requires the University to report conflicts that cannot be satisfactorily managed, reduced, or eliminated.] 3 FINAL 10/1/04 Violations of Conflict of Interest Policy Whenever an Investigator has violated this policy or the terms of any resolution plan required by the Conflict Review Committee (including failure to file or knowingly filing incomplete, erroneous, or misleading disclosure forms) the Vice President for Finance and Support Operations shall notify the Provost, who will impose sanctions or institute disciplinary proceedings against the violating individual. If the violation results in a collateral proceeding under College policies regarding research misconduct, then the Provost will defer decision on sanctions until the misconduct process is completed. In addition, the University shall follow Federal regulations regarding the notification of the sponsoring agency in the event an Investigator has failed to comply with this policy. The sponsor may take its own action as it deems appropriate, including the suspension of funding for the Investigator until the matter is resolved. Record Maintenance Records of investigator financial disclosures and of actions taken to manage actual or potential conflicts of interest, shall be retained by the Vice President for Finance and Support Operation’s Office until 3 years after the letter of the termination or completion of the award to which they relate, or the resolution of any government action involving those records. Collaborative Projects/Subagreements Collaborators/subrecipients/subcontractors from other organizations must either comply with this policy or provide a certification that their organizations are in compliance with Federal policies regarding investigator significant financial interest disclosure and that their portion of the project is in compliance with their institutional policies. 4