Conflict of Interest Policy & Disclosure Process

1. Conflict of InterestPolicy & Disclosure Process Member Overview

2. Purpose ● Overview of the Conflict of Interest Policy ● Requirements for Disclosure ● Steps in the Disclosure Process

3. Policy • IRS Requirement: • Policy with guidelines and principles for reporting and managing actual, potential and perceived Conflicts of Interest • Policy approved September, 2009 • Assists faculty, staff and students in maintaining the highest level of integrityin all University endeavors

4. Members In a position to influence or commit University resources • Faculty • Staff • Members • Post-Doctoral Scholars • Students

5. Definition An actual Conflict of Interest arises in a situation where financial or other personal or professional considerations compromise an individual’s: • Objectivity • Professional Judgment • Professional Integrity • Ability to perform responsibilities to the University

6. Issues Gray areas: Potential or Perceived Conflicts of Interest Could appear to others to be a Conflict of Interest Individual, Individual’s family or close relation University commitment to address proactively Eliminate anyone’s integrity from being questioned

7. Faculty Example ● Objectivity ● Professional Integrity

8. Staff Example ● Objectivity ● Professional Judgment

9. Office of General Counsel • Facilitates the Conflict of Interest Disclosure and Management Process • Maintains an electronic disclosure system • Serves as a resource for the University community

10. Disclosure Process Overview • Individual Completes Disclosure On-line • Oversight by Responsible Parties • Designated Reviewer Evaluates Disclosure • University Conflicts Committee Reviews • Reviewer Creates Management Plan

11. Disclosure Oversight Review Disclosure UCC Plan To an existing actual, perceived or potential Conflict of Interest When a new interest or activity is identified that may create an actual, perceived or potential Conflict of Interest

12. Disclosure Oversight Review Disclosure UCC Plan Update Disclosure examples: • Acquiring a new financial interest in a third party entity • Proposing new research where the Cayuse system identifies a need for an update • Serving in a new capacity at the University where the individual’s interest and activities now may pose a Conflict of Interest

13. Disclosure Oversight Review Disclosure UCC Plan Log-in screen:

14. Disclosure Oversight Review Disclosure UCC Plan

15. Disclosure Oversight Review Disclosure UCC Plan

16. Disclosure Oversight Review Disclosure UCC Plan

17. Disclosure Oversight Review Disclosure UCC Plan

18. Disclosure Oversight Review Disclosure UCC Plan

19. Disclosure Oversight Review Disclosure UCC Plan

20. Disclosure Oversight Review Disclosure UCC Plan

21. Disclosure Oversight Review Reviewer Evaluation UCC Plan Reviewer Responsible for: ● Ensuring full and accurate information ● Identifying any actual, potential or perceived conflicts of interest ● Recommending a plan to the UCC to manage any conflicts When a Disclosure is from a Faculty Member, the Reviewer may elect to forward the Faculty Member’s disclosure to the Faculty Conflict Committee (FCC) for review. For additional information on the FCC, refer to the COI policy at http://policy.nd.edu

22. Disclosure Oversight Review Reviewer Evaluation UCC Plan • Disclosure Questionnaire • 15 days Member • All Negative Responses • 15 days Reviewer • Disclosure Process Complete System

23. Disclosure Oversight Review Reviewer Evaluation UCC Plan • Disclosure Questionnaire Member • Up to15 days to complete • Any Affirmative Responses • Up to15 days to complete Reviewer • Management Plan • Typically 1 week Reviewer and Member • Response • Up to 30 days University Conflicts Committee

24. Disclosure Oversight Review Management Plan UCC Plan Manage, Reduce, Eliminate

25. Disclosure Oversight Review Management Plan UCC Plan Manage, Reduce, Eliminate

26. Disclosure Oversight Review Management Plan UCC Plan

27. Disclosure Oversight Review Management Plan UCC Plan

28. Disclosure Oversight Review Management Plan UCC Plan

29. Disclosure Oversight Review UCC Review UCC Plan UCC will determine whether an actual, perceived or potential Conflict of Interest exists UCC will approve, amend or veto the proposed Management Plan within 30 days • Executive VP; Provost; VP for Research; VP & General Counsel • University Conflicts Committee Request for reconsideration within 15 calendar days Subsequent decision of UCC is final • Oversees Training, Education and Policy Modifications • Ensures Proper Management of all COI’s

30. Disclosure Oversight Review Oversight UCC Plan Reviewer Oversight Manager Member Management Plan 12 months

31. Integrity Disclosure Process • Individual Completes Disclosure On-line No paper form E-mail notice annually Updates on-line Quick review Timely follow-up Communication • Oversight by Responsible Parties • Designated Reviewer Evaluates Disclosure • University Conflicts Committee Reviews • Reviewer Creates Management Plan

32. Additional Resources • Please contact: Office of the General Counsel 631-6411 or policy@nd.edu ● Select in top right corner or visit: http://conflictpolicy.nd.edu 1 - Power point slides with narrative comments 2 - Navigation Guide 3 - Disclosure Guide • Any technical questions regarding the disclosure system may be directed to the OIT Help Desk at 631-8111 • Visit http://policy.nd.edu/ to view the University Conflict of Interest Policy in its entirety