1. Crisis And Conflict Management

2. Conflicts of Interest Lecture 20 2

3. Conflict of Interest 3

4. DEFINITIONS 1.COIs are the “temporal existence of conflicting primary and secondary interests.” 2. COIs occur “whenever financial considerations may compromise or have the appearance of compromising an investigator’s professional judgment and independence in designing, conducting, or reporting research.” 4

5. “REASONABLE PERSON” TEST FOR COIs If a reasonable person concludes that it is likely that an individual might emphasize personal interests over other interests for which he/she has responsibility 5 Sponsored Programs

6. COIs REQUIRE PRESENCE OF THREE ELEMENTS 6 + + 1.Acting in a professional or official capacity or in a position of trust 2.While having a personal interest (usually financial) 3. That interferes with objective decision making (or gives the impression that decision making is compromised)

7. 7 + + Having a conflict of interest is not necessarily a problem or a “bad thing”. Having a conflict of interest and doing nothing about it is a problem!

8. INTERESTS COME IN TWO BASIC FORMS 8 Financial (tangible) Non-Financial (intangible) Money Professional Employment  Personal Property/Stock Ownership Physical  Psychological

9. TYPICAL COIs 9 Maintaining roles that conflict Accepting personal gratuities Influence Peddling Use of public property to fulfill private obligations Using or disclosing confidential information Conflicting outside employment or other allegiances (i.e., boards)

10. MOST COMMON FACULTY COI SITUATIONS 10 Consulting Licensing University technology Studies involving risk to human subjects Procurement Mentoring

11. TO WHOM DO FACULTY RESEARCHERS HAVE A RESPONSIBILITY? 11 Students/Trainees Employees Employers State Taxpayers Society (“Public Trust”)

12. HOW UNIVERSITIES HANDLE COIs 12 Step One: Always disclose! Apply the “Front Page of the Atlanta Journal Constitution” test

13. HOW UNIVERSITIES HANDLE COIs 13 Step Two: Mitigate and manage, where possible Modify research design Monitor research by independent reviewers

14. HOW UNIVERSITIES HANDLE COIs 14 Step Three: If monitoring is not feasible, you may be required to: Discontinue the compensated activity Divest self of the financial interest Terminate the research

15. FACULTY COI SITUATIONS 15 Consulting Must balance the researcher’s responsibility to the institution, to students, and to the company.

16. FACULTY COI SITUATIONS 16 Common Consulting Mistakes Limiting publication rights Creating the impression your University has sanctioned the consulting Taking time away from primary University duties Giving away or bartering ownership and intellectual property (IP) rights

17. FACULTY COI SITUATIONS 17 Consulting at UGA UGA requires disclosure and prior approval of all consulting relationships Each college/school has its own consulting request/approval form Other USG institutions have their own consulting policies

18. FACULTY COI SITUATIONS 18 Consulting Cautions Do not consult for a company that requires you to devote time and effort already committed to the university Be cautious when entering into relationships that limit publication Refrain from creating any impression that the university has sanctioned the outside activity, if it hasn’t Do not use any university resources for your consulting without written permission. Do not use students to support your consulting activities Seek advice from your dean or Sponsored Programs representative before accepting consulting agreements that may limit future sponsored activities

19. FACULTY COI SITUATIONS 19 Licensing Intellectual Property Licensing transactions present many potential COIs, especially those involving start-up companies where your institution and inventors have a continuing relationship.

20. FACULTY COI SITUATIONS 20 Licensing Issues Establishing a company based on a license of institution-owned technology Distributing equity in that company to the inventor and the University and managing it Providing sponsored research from the company back to the University Managing research in areas closely related to the licensed technology Supervising students and other University employees in the context of the relationship between the university and the start- up

21. FACULTY COI SITUATIONS 21 Licensing Cautions Simultaneously wearing a faculty hat and a company hat creates a COI; if the company also funds your faculty research, your COI just grew exponentially! Be careful about involving students and other University staff in research for which you have a COI Stay out of negotiations between your University and your company---if you can! If your commitment to your academic job suffers because of your company activities, consider taking a leave of absence

22. FACULTY COI SITUATIONS 22 Research It is critical that humans who volunteer as participants be assured that no bias is influencing the study Potential Places for Bias 1. Study design 2. Subject recruitment 3. Gathering data 4. Interpreting data 5. Reporting data

23. FACULTY COI SITUATIONS 23 Clinical Research If real financial COIs exist, they must be addressed in the most conservative manner Scientific objectivity and ethics are at stake! The utmost attention must be paid to avoid COIs involving human subjects Your IRB approval is contingent upon resolution of COIs

24. FACULTY COI SITUATIONS 24 Research Cautions Disclose all financial relationships The greater the risk to volunteers, the more likely an institution will be to limit or bar faculty with significant financial interests from participating in the study The more complex and closer the activities of the faculty member are to the business interests of the company, the more likely the institution will be to restrict the faculty members’ multiple roles Avoid conducting clinical trials when both the institution and the investigator have financial interests in the outcome of clinical studies

25. FACULTY COI SITUATIONS 25 Procurement In Georgia, investigators can’t acquire goods and services from companies in which they have an interest, except under certain circumstances (i.e., unless the COI is managed, mitigated, or eliminated)

26. FACULTY COI SITUATIONS 26 Procurement Cautions Disclose the same for family members

27. FACULTY COI SITUATIONS 27 Mentoring Graduate Students Post-Docs Junior Faculty Colleagues

28. FACULTY COI SITUATIONS 28 Mentoring Special relationship of trust Unequal distribution of power Potential for damage to mentee’s training or career development

29. FACULTY COI SITUATIONS 29 Mentoring Cautions Protection of mentee’s rights to publish must be paramount Mentees have the “right to know” about mentors’ COIs COIs involving mentoring should be monitored A. Assign mentoring responsibilities to another colleague B. Use Ombudsman oversight or other management strategies C. Eliminate COI

30. REALITY CHECK 30 Many people believe that they are too moral or too wise to have conflicts. Too many people believe they have the wisdom and virtue to manage their own conflicts of interest.

31. Summary Conflict of interest Typical Conflict of Interest Steps how university handle COI. Faculty Conflict Reality Check 31

32. Thank you 32