1. IUPUI Research Coordinators’ Meeting Sherry A. Oswalt, J.D. Conflict of Interest Manager Wednesday, June 11, 2008 12:00 P.M.

2. About COI at IUPUI… Where did this all come from? Where did this all come from? Why am I hearing so much about this now? Why am I hearing so much about this now? Who are you and what do you do? Who are you and what do you do?

3. What is a Conflict of Interest? A financial interest that has the or bias the professional judgment or objectivity of the holder of the interest OR has the appearance of having the potential to compromise or bias the professional judgment or objectivity of the holder of the interest. A financial interest that has the potential to compromise or bias the professional judgment or objectivity of the holder of the interest OR has the appearance of having the potential to compromise or bias the professional judgment or objectivity of the holder of the interest.

4. IU Policy Purpose: 1. The assurance of objectivity in research, teaching, professional service and administration to preserve the credibility of the University and the individuals engaged in these endeavors; and 2. To ensure that individual financial interests do not influence our commitment to uphold ethical standards for the protection of human subjects.

5. Why is this such a big deal? Jeopardize public faith in research findings if there is the belief that the investigator is acting in his/her own best interests. Jeopardize public faith in research findings if there is the belief that the investigator is acting in his/her own best interests. Damage to the University’s and investigator’s reputations. Damage to the University’s and investigator’s reputations. Reduction in the public’s willingness to participate in studies if perception of research is compromised. Reduction in the public’s willingness to participate in studies if perception of research is compromised. Funding may be inhibited or delayed. Funding may be inhibited or delayed. Discoveries may be inhibited or delayed if less support is available for research. Discoveries may be inhibited or delayed if less support is available for research. Ability to attract and retain top faculty and students may be decreased due to reputational damage. Ability to attract and retain top faculty and students may be decreased due to reputational damage.

6. In addition… A conflict of interest can exist when there is no allegation that an individual actually acted improperly. The threshold relates to the appearances and possibilities. A conflict of interest can exist when there is no allegation that an individual actually acted improperly. The threshold relates to the appearances and possibilities. The NIH considers an Investigator’s opportunity for personal gain to be “intrinsically unacceptable” therefore conflicts or potential conflicts must be managed. The NIH considers an Investigator’s opportunity for personal gain to be “intrinsically unacceptable” therefore conflicts or potential conflicts must be managed.

7. COI General Rule A conflict of interest always involve the appearance or actual use of an individual’s authority for personal and/or financial gain.

8. Stories Reported Recently in…

9. To Whom Does IU Policy Apply? All Academic Appointees, including part-time and visiting faculty, faculty who are neither tenured nor on tenure-track appointments, lecturers, and academic specialists; All Academic Appointees, including part-time and visiting faculty, faculty who are neither tenured nor on tenure-track appointments, lecturers, and academic specialists; Students and anyone else who is involved in the design, conduct, or reporting of research; and Students and anyone else who is involved in the design, conduct, or reporting of research; and Retired faculty to the extent that they are still actively performing research, teaching, or providing service under the auspices of the University. Retired faculty to the extent that they are still actively performing research, teaching, or providing service under the auspices of the University.

10. Coming Soon… Improved conflict of interest disclosure process. Improved conflict of interest disclosure process. Educational sessions to detail conflict of interest, demonstrate improved disclosure process and answer any questions. Educational sessions to detail conflict of interest, demonstrate improved disclosure process and answer any questions.

11. Important Dates for COI 2008 COI Disclosures are due September 1 st. 2008 COI Disclosures are due September 1 st. The new web-based disclosure system will be rolled out in August of 2008. The new web-based disclosure system will be rolled out in August of 2008. Training sessions will be scheduled with each campus school and any other divisions or offices who would like training. Meetings will be held in August. Training sessions will be scheduled with each campus school and any other divisions or offices who would like training. Meetings will be held in August.

12. COI Office Responsibilities The Conflict of Interest Office is the campus resource for conflict of interest issues. As such, we: The Conflict of Interest Office is the campus resource for conflict of interest issues. As such, we: -Manage the conflict of interest disclosure process. -Prepare analysis of disclosures for the Conflict of Interest Committee to review. -

13. COI Office Responsibilities (Cont.) Consult with appropriate individuals in drafting conflict of interest management plans. -Coordinate with Research Administration staff regarding IRB reviews and new and review contracts and awards. -Review and provide guidance to unit level officials when drafting local conflict of interest guidelines.

14. COI Office Responsibilities (Cont.) -Conduct educational sessions with the various schools on campus. -Conduct meetings with various faculty members to discuss conflict of interest issues. -Provide suggested language for revised procedures and other documents and forms.

15. Questions?Concerns?Suggestions?

16. Contact Information Conflict of Interest Office Conflict of Interest Office iupuicoi@iupui.edu Sherry Oswalt Sherry Oswalt Conflict of Interest Manager soswalt@iupui.edu 4-7307