1. Conflict of Interest Faculty & Staff of Instruction or Research Human Resources 2011

2. Outline  Why Conflict of Interest Matters and Risks of Non-Disclosure  What is a Conflict of Interest?  Clarkson’s Conflict of Interest Policy  Types of Conflict  Responsibilities  Disclosure & Evaluation Process  Potential Conflicts of Interest  COI Resources  Conclusion

3. Why Conflict of Interest Disclosure Matters?  Conflicts of Interest, especially those of a financial nature, have the potential to threaten the integrity of a university’s research, scholarship, instruction, evaluation, and administrative functions.  To ensure that Clarkson’s reputation and research programs are not compromised by even an appearance of inattention to this matter, Clarkson has put in place policies consistent with federal guidelines that require the reporting and management of the potential Conflicts of Interest of its faculty, investigators, administrators, and staff.

4. What is a Conflict of Interest?  A Conflict of Interest arises when an individual's private interests (such as outside professional or financial relationships) might interfere or have the perception to interfere with his or her professional obligations to Clarkson.  Such situations do NOT necessarily imply wrong-doing or inappropriate activities.  However, in a university setting, they can compromise, or be perceived as compromising, important academic values, research integrity, or the university mission.  At Clarkson, it is essential for all employees (hereafter “members”) to understand how these divergent interests can become a issue.

5. Clarkson’s Conflict of Interest Policy  Applies to Members of the University community (Board of Trustees, executive officers, deans, directors, faculty and staff), their spouses, and dependent children.  All Members:  Have a primary commitment to the University.  Have an obligation to make decisions in a way that promote the best interests of the institution.  Will conduct their relationships with each other and the University with honesty and integrity.  Need to be sensitive and aware of the possible adverse effects of their external activities.

6. Clarkson’s Conflict of Interest Policy  All Members (cont.):  Are required to identify, evaluate, and disclose potential Conflicts of Interest that may appear to compromise their obligation to the University.  Must disclose Conflicts of Interest at the time of first appearance or identification.  Responsibility lies with the Institution to determine:  If disclosed potential conflicts are evaluated in order to determine if an actual conflict of interest exists.  What conditions or restrictions should be in place to eliminate, reduce, or manage any potential or actual Conflict of Interest.

7. Types of Conflict 1.Conflict of Commitment 2.Conflict of Interest Conflict of Commitment: A Conflict of Commitment arises when a member undertakes external commitments which interfere with member’s obligations and commitments to Clarkson. –Compete with the University’s mission. –Interfere with the ability perform the responsibilities associated with his or her position.

8. What can cause a Conflict of Commitment?  External consulting by staff, if greater than the allowable limit.  Officer or Director in outside organizations, including churches and nonprofit organizations.  Start-up or other entrepreneurial businesses Note: A conflict of commitment can often exists alongside of a conflict of interest and both may need to be addressed at the same time.

9. Types of Conflict Conflict of Interest: A Conflict of Interest may arise when a member has the opportunity to influence the University’s business, administrative, academic or other decisions in ways that could lead to personal gain or advantage of any kind.

10. Types of Conflict Conflict of Interest (Continued): Additionally, for Members of the Faculty and Staff of Instruction and Research (hereafter “Investigator”), a Conflict of Interest exists when a Significant Financial Interest, as defined below, could directly and significantly affect the design, conduct, or reporting of sponsor funded research activities.

11. Significant Financial Interest Significant Financial Interest is defined by the regulation as 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).

12. Significant Financial Interest Significant Financial Interest does not include:  salary, royalties, or other remuneration from the Institution;  income from seminars, lectures, or teaching engagements sponsored by public or nonprofit entities;  income from service on advisory committees or review panels for public or nonprofit entities  an equity interest that when aggregated for the Investigator and the Investigator's spouse and dependent children, meets both the following tests: 1) does not exceed $10,000 in value as determined through reference to public prices or other reasonable measures of fair market value and 2) does not represent more than a five percent ownership interest in any single entity; or  salary, royalties or other payments that when aggregated for the Investigator and the Investigator's spouse and dependent children over the next twelve months are not expected to exceed $10,000.  Participation in mutual funds that are not directed or controlled by the Investigator or Investigator's spouse and dependent children.

13. Institutional Responsibilities  Create and maintain a written policy.  Inform each Investigator of the regulation, of the Conflict of Interest Policy, and of the their disclosure responsibilities.  Designate an institutional official(s) to solicit and review financial disclosure statements from each Investigator.  Review each disclosure and determine whether a conflict of interest exists.  Implement appropriate actions to manage, reduce, or eliminate Conflicts of Interest.  Maintain records of all financial disclosures and all actions taken by the Institution.  Establish adequate enforcement mechanisms  Certify that the Institution complies with the Conflict of Interest regulations with respect to all research proposals and projects.

14. Institutional Responsibilities  Prior to proposal submission, require that each Investigator has submitted a current Conflict of Interest Disclosure Form, including a listing of his/her known Significant Financial Interests that relate to the sponsored research activity.  Report the existence of any Conflict of Interest to the funding agency:  Prior to expenditure of any funds under the award, the Institution may be required to report the existence of an Conflict of Interest to the funding agency and ensure that the conflicting interest has been managed, reduced, or eliminated.  Conflicts of Interest identified subsequent to the expenditure of any funds, as described above and within 60 days of that identification.  Respond to all requests by the funding agency regarding any identified Conflicts of Interest.

15. Investigator Disclosure Responsibilities  Complete and submit a Conflict of Interest Disclosure Form annually:  Disclose all potential Conflicts of Interest and Conflicts of Commitment (including spouse and dependent children) that may appear to compromise their obligation to the University.  Disclose all Significant Financial Interests (including spouse and dependent children) that relate to your participation in any sponsor funded research activity.  Submit an updated Conflict of Interest Disclosure Form:  When any new potential conflicts are first identified, including Significant Financial Interests.  During the research proposal process, Principal Investigators must certify that there are no changes since most current disclosure was submitted.

16. Activities That May Warrant Updated Disclosures  Updated Conflict of Interest Disclosure Forms may be necessary before engaging in certain sponsor funded activities.  Investigators should evaluate the following activities before engagement:  When submitting proposals or accepting awards  When submitting IRB applications  Before involvement in technology transfer  Prior to business start-up

17. Evaluation Process Director of Research reviews each Conflict of Interest Disclosure Form considering the following: 1.Establish Context  What are the external and organizational factors that impact on this situation?  Identify research activities that have an impact on this situation 2.Identify and Analyze Risks  What potential risks to the University’s objectives, policies, are present in the conflict situation?  Does the conflict appear to be affected by any research activities  Are the individual’s financial interests appear to be affected by any research activities 3.Evaluate Likelihood and Consequence of Risk, and any mitigating practices that are in place  Likelihood rare………..almost certain  Consequences low………..very high 4.Treat Risk  Ensure that the conflict has been managed, reduced, or eliminated.

18. Evaluation Process Once reviewed, the Director of Research may do the following:  Request additional information  Review the disclosure with the Investigator to determine if potential or actual conflicts exist.  Eliminate, reduce, or manage potential or actual conflicts.  Refer the disclosure to a Conflict of Interest Committee who will review the disclosure.

19. Managing Conflict of Interest Examples of conditions or restrictions that may occur in the management of any potential or actual Conflict of Interest may include, but are not limited to the following:  Disclosure to the funding agency.  Monitoring research by an independent reviewer.  Modification of the research plan.  Disqualification from participation in the portion of research affected by the financial interests.  Divestiture of financial interests.  Severance of relationships that create the conflict.  The institution may notify the external agency that the University is unable to manage an actual or potential conflict of interest.

20. Potential Conflicts of Interest That Should Be Disclosed 1.Purchasing equipment, instruments, or supplies from sponsored funds for research from a firm in which the principal investigator has a financial interest. 2.Giving well-paid lectures or consulting for companies or organizations whose economic interests are affected by the investigator’s work that are supported by sponsored funds. 3.Commitments that involve frequent or prolonged absences from the University on non University business. 4.A member may not possess a substantial interest in or participate in the profits of any organization that deals or seeks to deal with the University without full disclosure of relevant facts.

21. Potential Conflicts of Interest That Should Be Disclosed 5.Researcher has a Significant Financial Interest in a company that is sponsoring his/her University research. 6.Researcher conducts federally sponsored research on a product (e.g., cancer detection method). Researcher also consults for the company that intends to manufacture and market the cancer detection method. 7.Researcher conducts privately sponsored research and also consults for the sponsoring company.

22. Potential Conflicts of Interest That Should Be Disclosed 8.Faculty member is on an advisory committee for a for-profit company. The company sponsors the faculty’s research to test a product on human participants. 9.A faculty member has a startup company that requests to use University facilities to continue work for the startup company.

23. Conflict of Interest Tools Clarkson Policies and Forms  Conflict of Interest Policy http://www.clarkson.edu/dor/compliance/COI.html  Conflict of Interest Disclosure Forms http://www.clarkson.edu/dor/compliance/COI.html  Start-up Business Ventures Guidance http://www.clarkson.edu/dor/tech_transfers.html  Intellectual Property Policy http://www.clarkson.edu/dor/tech_transfers.html

24. Conclusion This concludes the self-guided conflict of interest review. Please proceed to Step 2 and complete the quiz. Thank You!