1. What’s Going on in the Conflict of Interest World? Michelle Evans Research Integrity Office February 16, 2011

3. Conflict of Interest Discussion Today, we will discuss: Agenda  Introductions  What is COI?  Importance of Reporting  Federal Guidelines and Duke COI Policy  Recent NIH Developments  Institutional COI  Examples of COI - Cases  Take It Away, Charlotte

4. Importance of Reporting Transparency NIH funding Duke Internal Audit Change in national culture

5. Why Do We Care about COI? Protection of human subjects. Protection of human subjects. Protection of our faculty and institution. Protection of our faculty and institution. Federal regulations and requirements. Federal regulations and requirements. Maintain the public’s trust. Maintain the public’s trust. Complete transparency. Complete transparency. Cases like the ones we will discuss today. Cases like the ones we will discuss today.

6. Where Does Duke Stand Nationally? 1) 1) One of the largest portfolios of management plans. 2) 2) Only program using the DSMBplus model. 3) 3) Generally, 10% of all conflicts reported to NIH (eRA Commons) are from Duke. 4) 4) MIDDLE OF THE ROAD – Much more flexible than most academic medical centers.

7. Defining Conflict of Interest Defined: A conflict of interest involves the abuse -- actual, apparent, or potential -- of the trust that people have in professionals. The simplest working definition states: A conflict of interest is a situation in which financial or other personal considerations have the potential to compromise or bias professional judgment and objectivity. An apparent conflict of interest is one in which a reasonable person would think that the professional’s judgment is likely to be compromised. A potential conflict of interest involves a situation that may develop into an actual conflict of interest. *It is important to note that a conflict of interest exists whether or not decisions are affected by a personal interest; a conflict of interest implies only the potential for bias, not a likelihood. Office of Research Integrity, Health and Human Services

8. Types of Conflict Personal vs. Institutional Personal vs. Institutional Financial vs. Other Financial vs. Other-Prestige-Promotion/Tenure-Reputation -Belief in idea/theory -Purchasing-Nepotism-Clinical

9. What is Disclosure? Reporting vs. Disclosure Reporting vs. Disclosure Types of Disclosure Types of Disclosure -Consent documents -Publications-Presentations-Contracts-FDA-NIH

10. NIH Requirements for COI NIH requires grantees and investigators to comply with requirements of 42 CFR Part 50, Subpart F for research where PHS funding is sought. Organizations must : Have a written and enforced administrative process to identify and manage, reduce, or eliminate conflicting financial interests with respect to research projects for which NIH funding is sought. Have a written and enforced administrative process to identify and manage, reduce, or eliminate conflicting financial interests with respect to research projects for which NIH funding is sought. Before spending any NIH funds awarded under a new award, inform the Grants Management Officer (GMO) of the existence of any conflicting financial interests. Before spending any NIH funds awarded under a new award, inform the Grants Management Officer (GMO) of the existence of any conflicting financial interests.

11. NIH Requirements When informing the GMO that a financial COI has been identified, ensure the interest has been addressed in accordance with the regulations by indicating whether the conflict has either been managed, reduced, or eliminated. When informing the GMO that a financial COI has been identified, ensure the interest has been addressed in accordance with the regulations by indicating whether the conflict has either been managed, reduced, or eliminated. Continue to make similar reports on subsequently identified conflicts within 60 days of identifying them. Continue to make similar reports on subsequently identified conflicts within 60 days of identifying them. Make additional information available to NIH, upon request, as to how it handled conflicting interests in accordance with regulations. Make additional information available to NIH, upon request, as to how it handled conflicting interests in accordance with regulations.

12. For NIH – Who Must Disclose? Investigators must have submitted at time of application for PHS funding. Investigators must have submitted at time of application for PHS funding. Investigators include principal investigators and any other person who is responsible for the design, conduct, or reporting of research funded by PHS, or proposed for such funding. Investigators include principal investigators and any other person who is responsible for the design, conduct, or reporting of research funded by PHS, or proposed for such funding. Update on an annual basis or as new reportable significant financial interests are obtained. Update on an annual basis or as new reportable significant financial interests are obtained. NIH has a $10,000 de minimis (threshold). NIH has a $10,000 de minimis (threshold).

13. Duke COI Policy Faculty and required staff submit an electronic COI reporting form annually and within 10 days of a change of status. Form is routed to the Research Integrity Office. Report any extramural relationships with entities that may conduct business with Duke and an IRS Form 1099, W-2, or K-1 is received.

14. Duke COI Policy Examples of relationships that may present a potential COI -Royalties-Advisory board position -Consulting-Speaking honoraria -Equity-Intellectual property -Options-Gifts *Some Duke people submit an administrative COI form.

15. COI Ranges $0 to $9,999 Report; no management $10,000 to $24,999Report; management plan (MP) req’d Typically disclosure $25,000 and aboveReport; management plan required Restrictions imposed Publically-traded equityReport; MP required if $10K or >5% Privately-held equityReport; MP required and treated like >$25K Intellectual propertyReport; MP required if licensed Institutional COIManagement plan may be required May require external oversight such as DSMBplus and external IRB

16. Duke Proposal Application Form Financial relationships. Investigator should always mark the DPAF for COI questions. DPAF asked about a relationship with that particular organization. DPAF routing process. eIRB Application Financial relationships. Investigator should always mark the eIRB application for COI questions. IRB routing process.

17. New COI Frontiers NIH Notice of Proposed Rule Making Change in de minimis to $5,000. Institution decides about COI rather than investigator. Management plan must be issued timely. If not, mitigation plan required. More info about COI reported.

18. New COI Frontiers Continued Annual updates to NIH about the COI. SBIR/STTR carve-outs are now included. FCOI training for investigators. BIGGEST IMPACT – no grant funds released until grant is reviewed by RIO for COI.

19. Institutional COI Policy effective January 1, 2010. Policy effective January 1, 2010. Duke is one of the only a few national programs developing systems for ICOI. Duke is one of the only a few national programs developing systems for ICOI. Covers the following conflicts Duke may have: 1) Gifts 2) Covered Officials 3) Intellectual property

20. Institutional COI Possible Management Strategies 1) Disclosure. 2) DSMBplus/Oversight. 3) External IRB (Duke is secondary reviewer.). 4) Patient advocate. MORE TO COME SOON!

21. Case Scenarios Dr. Smith consults for Good Time Pharmaceuticals receiving $15,000 in 2010. GTP sponsors 2 clinical trials on which Dr. Smith serves as PI. Dr. Smith consults for Good Time Pharmaceuticals receiving $15,000 in 2010. GTP sponsors 2 clinical trials on which Dr. Smith serves as PI. Dr. Happy serves on the advisory board for Miller Medical Devices and is paid $30,000. Dr. Happy has an NIH-funded study that includes comparing three medical devices, one of which is manufactured by Miller. Dr. Happy serves on the advisory board for Miller Medical Devices and is paid $30,000. Dr. Happy has an NIH-funded study that includes comparing three medical devices, one of which is manufactured by Miller.

22. Case Scenarios Dr. Johnson created a new assessment scale for evaluating bi-polar disorder and is listed on the copyright for the scale. The scale has been licensed to Feel Good Pharma. Feel Good pays Dr. Johnson royalties as a result of the license. What type of role can Dr. Johnson have in ongoing research related to the scale? Is this also an potential ICOI? Dr. Johnson created a new assessment scale for evaluating bi-polar disorder and is listed on the copyright for the scale. The scale has been licensed to Feel Good Pharma. Feel Good pays Dr. Johnson royalties as a result of the license. What type of role can Dr. Johnson have in ongoing research related to the scale? Is this also an potential ICOI?

23. Case Scenarios Dr. Adamson received $50,000 in consulting income from the Sunshine Company for consulting. Dr. Adamson’s wonderful grant administrator emailed RIO to ask about his positive DPAF for a new clinical trial. Dr. Adamson received $50,000 in consulting income from the Sunshine Company for consulting. Dr. Adamson’s wonderful grant administrator emailed RIO to ask about his positive DPAF for a new clinical trial. Guess what happened?

24. We Need Your Help! Make certain correct email address are in Enterprise Directory. Chasing folks to report. Gift inquiries. Transfer PI positions. Work with IRB to change consents. Send RIO reports from your DSMBplus and external IRB.

25. We Need Your Help! Notify the Research Integrity Office of any possible conflicts of interest and ask investigator to update their reporting form. Feel free to call with any questions.

26. Who Do You Call? Research Integrity Office Room 110, Seeley G. Mudd Michelle Evans 684-6739 Susan Brooks 684-6757 Angie Solomon 684-1822 COI Website http://www.medschool.duke.edu/modules/som_interests/index.php?id=1

27. IRB Perspective on Financial COI Disclosures Charlotte Coley Director, IRB Educational Programs Charlotte Coley Director, IRB Educational Programs

28. IRB Responses to COI  Inclusion in Consent Form  External IRB Use Phase III, IV multi-site, industry sponsored studies Institutional COI  Inclusion in Consent Form  External IRB Use Phase III, IV multi-site, industry sponsored studies Institutional COI

29. IRB COI Language "Dr. _________ has received personal compensation from the sponsor of this study in the past for his/her work on ____________________ and may receive personal compensation from the sponsor in the future.”

30. Institutional COI Definition Institutional Conflict of Interest in Research: An Institutional COI in Research may occur whenever the financial interests of the institution, or of an institutional official who has authority to act on behalf of the institution, might affect—or reasonably appear to affect—institutional processes for the design, conduct, reporting, review, or oversight of research. Institutional Conflict of Interest in Research: An Institutional COI in Research may occur whenever the financial interests of the institution, or of an institutional official who has authority to act on behalf of the institution, might affect—or reasonably appear to affect—institutional processes for the design, conduct, reporting, review, or oversight of research.

31. Institutional COI – Covered Officials  Board of Trustees,  President,  Chancellor & Vice Chancellors  Provost & Vice-Provosts  Deans & Vice-Deans  Associate Deans &  Other Institutional administators  Board of Trustees,  President,  Chancellor & Vice Chancellors  Provost & Vice-Provosts  Deans & Vice-Deans  Associate Deans &  Other Institutional administators

32. IRB Responses to COI  Follow Management Plan  Management Plan shared with IRB Primary Reviewer  Follow Management Plan  Management Plan shared with IRB Primary Reviewer

33. Swiss Cheese Theory of Learning Charlotte Coley 2010 SAE reporting PI Responsibilities Protocol Deviations Definitions QA/QI 33 COI

34. IRB Responses to COI Need for Training  Additional One on One Training  Attend an IRB Meeting  Additional One on One Training  Attend an IRB Meeting

35. Resources  IRB Website: http://irb.duhs.duke.edu/ http://irb.duhs.duke.edu/  IRB HRPP Policies: http://irb.duhs.duke.edu/modules/irb_pols/index.ph p?id=3 http://irb.duhs.duke.edu/modules/irb_pols/index.ph p?id=3  eIRB Home: https://eirb.mc.duke.edu/eirb/Rooms/DisplayPages/LayoutInitial?Container=com.w ebridge.entity.Entity%5BOID%5BAC482809EC03C442A46F2C8EEC4D75D3%5D%5D https://eirb.mc.duke.edu/eirb/Rooms/DisplayPages/LayoutInitial?Container=com.w ebridge.entity.Entity%5BOID%5BAC482809EC03C442A46F2C8EEC4D75D3%5D%5D  IRB Website: http://irb.duhs.duke.edu/ http://irb.duhs.duke.edu/  IRB HRPP Policies: http://irb.duhs.duke.edu/modules/irb_pols/index.ph p?id=3 http://irb.duhs.duke.edu/modules/irb_pols/index.ph p?id=3  eIRB Home: https://eirb.mc.duke.edu/eirb/Rooms/DisplayPages/LayoutInitial?Container=com.w ebridge.entity.Entity%5BOID%5BAC482809EC03C442A46F2C8EEC4D75D3%5D%5D https://eirb.mc.duke.edu/eirb/Rooms/DisplayPages/LayoutInitial?Container=com.w ebridge.entity.Entity%5BOID%5BAC482809EC03C442A46F2C8EEC4D75D3%5D%5D

36. Contact Information Charlotte Coley coley007@mc.duke.edu 668-5111 IRB Office Main # 668-5119 My direct # Charlotte Coley coley007@mc.duke.edu 668-5111 IRB Office Main # 668-5119 My direct #