1. University of Pittsburgh Conflict of Interest Office A Partner in Promoting Integrity in Research, Teaching, and Administration

2. COI RESPONSIBILITIES FACULTY/STAFF DEVELOPMENT PROGRAM: COI DISCLOSURE & DEPARTMENTAL MANAGEMENT RESPONSIBILITIES COI Office: David Wehrle, Director Khrys Myrddin, Associate Director April 1, 2011

3. What is a Conflict of Interest? A potential Conflict of Interest may exist if an individual’s outside interests (especially financial) may affect, or perceive to affect, his/her research, teaching, or administrative activities at the University.

4. Examples of Potential Conflicts Example 1  Professor Maureen Belstein, faculty member/researcher  Serves on Scientific Advisory Board for National Tool Company (she earned $35,000 last year)  NTC wants to sponsor university research to evaluate new technologies  Professor Belstein wants to be PI on the study

5. Examples of Potential Conflicts (cont’d) Example 2  Dr. William Monardo, faculty member/ researcher  President/owner of Laboratory Solutions, Inc. (LSI)  Dr. Monardo’s research group purchases scientific supplies and equipment from LSI.

6. Examples of Potential Conflicts (cont’d) Example 3  The University was awarded a federal grant on which Dr. Ari Samuel serves as PI.  He subcontracted a portion of the work to Scanware for installation of eye-movement analysis software.  Dr. Samuel has an equity interest in this vendor.

7. Examples of Potential Conflicts (cont’d) Example 4  Dr. Maryann Ruecken developed a back brace, which was patented by the University  The technology is licensed to Strait & Narrow, Inc., a non-publicly held company; she receives royalties for the device through Pitt  She holds equity in the company  Dr. Ruecken is conducting federally sponsored research to further evaluate the technology.

8. Importance of COI Management If COI is not managed… protection of human subjects may be compromised; integrity of research may be at risk; the public may lose trust in the University and its research findings; the investigator/faculty member may lose the respect of the academic community; violation of scientific norms may result; University may lose public support and funding for research;

9. Importance of COI Management (cont’d) research results may be excessively delayed or not published; there may be a negative impact on students; University resources may be improperly used; increased government regulations may result; scandals or negative media attention may occur….

10. THE CHRONICLE of Higher Education Baylor College of Medicine Faces NIH Sanctions Over Financial Conflicts Paul Baskin  Tuesday, January 20, 2010 The NIH has ordered tougher financial disclosures on all grant applications from Baylor College of Medicine, [citing] ”serious concerns” about the college’s compliance with regulations governing conflicts of interest…. The doctors who spoke favorably of Vytorin ® included Christie M. Ballantyne…who collected $34,472 during a five-month period… The NIH informed the institution last month that the agency would impose ‘special award conditions” on all future grants.

11. Today’s topics Departmental responsibilities  Annual COI filing process  Using the Superform system  COI Oversight & Management

12. Today’s topics (cont’d) University-level COI Management  Research protocols  Entrepreneurial endeavors  Purchasing  Office of Research

13. Annual COI Filing Process University Policies  07-05-02 (COI – Designated Administrators and Staff)  11-01-03 Annual COI memo from the provost & executive vice chancellor

14. Policy 11-01-03 COI Policy for Faculty, Scholars, Researchers, Research Staff/Coordinators http://www.bc.pitt.edu/policies/policy/11/11-01-03.html  Revised March 2010  List of changes and policy flow charts are also available from the COI website: http://www.coi.pitt.edu/Policies/index.htm

15. Annual COI Filing Process: Who? Faculty/Researcher Form  All individuals with regular faculty appointments  Employees of any classification who “direct or can materially influence research, or who are responsible for the design, conduct, and reporting of research”  Part-time faculty members not conducting research are covered by this COI policy only to the extent that their outside financial interests would reasonably appear to be affected by their work for the University.  The policy does not apply to employees on unpaid leave from the University or to adjunct faculty.

16. Annual COI Filing Process: Who? (cont’d) Designated Administrator/Staff form  Deans, department chairs, division chiefs, and center directors with faculty appointments must complete both University forms.  Employees classified as Administrator IV or above;  Those of other classifications (including faculty) who are in a position to make, direct, or materially influence University business decisions (e.g., employees who have significant influence over the selection of outside vendors or providers of services);  P-card holders

17. Reporting Financial Relationships: When? Institutional Policies  Policies 11-01-03 and 07-05-02 require reporting of the outside interests of faculty, administrators, and investigators upon appointment by April 15 of each year whenever new outside interests are accrued using the Superform system https://coi.hs.pitt.edu https://coi.hs.pitt.edu

18. What is the Superform system? Superform Web site must be used to file COI disclosures (there is no paper form). All forms filed become part of a secure COI database, accessible only to authorized individuals. The Superform system includes reporting forms for only the University of Pittsburgh.  UPMC uses a separate system accessible through Infonet http://compliance.infonet.upmc.com/COI.htm http://compliance.infonet.upmc.com/COI.htm  UPMC is working on a combined form for dually-employed individuals.

19. Who Has Access to the COI Database? IRB/IACUC/CORID Purchasing Office of Research Internal Audit General Counsel COI Office COI Committee Chair Regional Campus Presidents/Deans/ Department Chairs Research administrators/coordinators

20. Who Has Access to the COI Database? (cont’d) Request access through the COI Office (requires name, HSConnect username, departmental affiliation, and level of access to be granted. i.e., basic or operational); operational access must be approved by supervisor.  Send request for access to rogershn@upmc.edurogershn@upmc.edu Research administrators with basic access can determine whether investigators have a current COI form on file;

21. Making disclosures—Using the Superform system Returning users:  Login using existing HSConnect account  Retrieve forgotten password Do not create a new account!  Update HSConnect profile  Change e-mail address/password New users:  Create an HSConnect account If links to forms do not appear on Welcome screen, confirm correct affiliation in profile

22. Making disclosures—Using the Superform system (cont’d) Select the form you wish to complete  First-time users must answer every question  Returning users will be taken to the Form Summary page Edit responses as applicable Review the Form Summary Click “Submit this form” Click “View and Print” (next to the form you wish to print)

23. Making disclosures—Using the Superform system (cont’d) Print and sign Signature Page (SP) Forward Faculty/Researcher SP to department chair for review and signature Forward Admin/Staff SP to the next higher administrator (who is at least at the level of director or department chair) for review and signature

24. COI Oversight by Supervisors Faculty/Researcher—Department Level (cont’d) Ensure that all required employees have signed and submitted a Signature Page by April 15 Department Chairs review Faculty/Researcher disclosures Prepare Management Reporting Forms (MRF) for individuals who disclosed outside interests

25. COI Oversight by Supervisors Faculty/Researcher—Department Level (cont’d) Management Reporting Form  Used to document all actions that have been taken to manage identified conflicts of interest University-level COIC Department level

26. COI Oversight by Supervisors Faculty/Researcher—Department Level (cont’d) Section A: Briefly describe all actions taken to manage conflicts of interest arising from the individual’s disclosed outside financial relationships 1. a. Ownership Interests in publicly traded companies b. Ownership Interests in non-publicly traded companies 2. Offices and Positions 3. Remunerative Activities 4. Outside employment of University of Pittsburgh students or staff

27. COI Oversight by Supervisors Faculty/Researcher—Department Level (cont’d) 5. Technology Transfer Activities 6.a. Other Transactions or Facts (Business transactions) b. Other Transactions or Facts (All other) 7.Federally sponsored research related to disclosed outside interest(s) 8.Industry-sponsored research related to disclosed outside interest(s)

28. COI Oversight by Supervisors Faculty/Researcher—Department Level (cont’d)  Section B. Do you have financial interests that may interfere or appear to interfere with your ability to provide an unbiased review of the individual’s disclosure? YES / NO If YES, provide an explanation below. The dean, campus president, provost, or senior vice chancellor for health sciences, as appropriate, will need to develop a plan to manage the outside interest(s) disclosed by this individual.

29. COI Oversight by Supervisors Faculty/Researcher—Department Level (cont’d)  Section C: Is disclosure alone of the individual’s potential conflict in abstracts, publications, presentations, press releases, and in proposals and applications for research funding sufficient to manage the conflict? YES / NO Answer Yes, if an individual's outside activities create no conflict with his/her University work, i.e., s/he is not conducting research of commercial interest to any company or making purchases from any company with which s/he has a relationship  If YES, please explain why no further management is necessary.  If NO, please provide a detailed description of the measures that were (or will be) taken to manage the outside interest (s) disclosed. Include a description of ongoing follow-up or monitoring, if appropriate.

30. COI Oversight by Supervisors Faculty/Researcher—Department Level (cont’d)  Section D. Do you consider this case satisfactorily resolved? YES / NO Answer No if any relationship requires COI management above and beyond disclosure; describe actions taken; e.g., SMP has been invoked for a clinical trial; a data monitoring committee was established for the individual’s research program; entrepreneurial activities are being overseen by the COI Committee, etc.  If NO, please schedule an appointment with the dean, campus president, provost, or senior vice chancellor for health sciences, as appropriate, for discussion and further action.

31. COI Oversight by Supervisors Faculty/Researcher—Department Level (cont’d) Prepare departmental Annual Data Summary report Submit Signature Pages, related MRFs, and department’s Annual Data Summary Report to dean for review  SPs on which no outside interests were disclosed do not need to be submitted to the dean

32. COI Oversight by Supervisors Faculty/Researcher—Dean’s Level Dean reviews forms received from chairs  Approves or modifies any MRFs, as necessary Prepares School’s Annual Data Summary Report  Submit Signature Pages, related MRFs, and Departments’ and School’s Annual Data Summary Reports to the provost or senior vice chancellor for the health sciences by May 15

33. COI Oversight by Supervisors Designated Administrators/Staff—Department Level Ensure all required employees have signed and submitted the SP by April 15 Supervisor reviews Designated Administrators/Staff disclosures  Supervisor should work with the employee to develop a plan to manage any potential COI and document it in the form of a memorandum (do not use the MRF)  NEW -- Prepares an Annual Data Summary Report and submits it to the next higher reporting authority within the responsibility center

34. COI Oversight by Supervisors Designated Administrators/Staff—Department Level Report unresolved conflicts to the provost, senior vice chancellor for the health sciences, or executive vice chancellor by May 15;  Hint: there should be no unresolved conflicts SPs and management plans of resolved conflicts should not be forwarded, but should be filed in the department.

35. COI Oversight Signature Pages, Management Reporting Forms, and Annual Data Summary Reports are ultimately forwarded to the COI Office by the provost or senior vice chancellor for the health sciences Everything you need for the annual COI filing process can be found at http://www.coi.pitt.edu/directive.htm http://www.coi.pitt.edu/directive.htm

36. Departmental COI Management Prospective approval from department chair or dean is required for  All outside professional activities, consultancies, speaking engagements, SABs  Involvement of students in outside entities or in research of interest to a company in which a faculty member has a financial interest  Purchasing from, or subcontracting work to, a company in which an individual has a financial interest Cannot use University facilities or resources Total time expenditures in all outside professional activities cannot exceed one day per week Note: staff members must conduct all outside activities on their own time

37. Departmental COI Management (cont’d) Department Chairs are responsible for the development of COI management plans for research not overseen by a regulatory committee

38. Departmental COI Management (cont’d) Management Options  Divestment or reduction of financial interest  Disclosure of COI in publications, presentations, press releases, abstracts, and in proposals and applications for research funding  Disclosure of potential COI to others involved in the research  Dilution of investigator’s role in study, i.e., cannot be PI, but may be co-investigator  Addition of a data steward to a particular research project  Establishment of an oversight committee

39. Proper use of students/staff by faculty members with outside interests Prospective review and approval of activities by students’ department chair or dean Formal notification of faculty members’ interest in an outside company  Faculty members should distribute Student/Staff Notification Form (available on COI web site) for signature by students/staff  Students/staff should discuss any concerns with faculty members’ non-conflicted supervisor and/or COI Office

40. Proper use of students/staff by faculty members with outside interests (cont’d) Work under approved Corporate Research Agreement (CRA) should correspond to effort provided for in the CRA (e.g., no overtime)  Cannot be compelled to perform work that will benefit the company  Compatibility with academic interests of students  Timely ability to publish research results for academic credit without hindrance by the company’s commercial interests

41. Proper use of students/staff by faculty members with outside interests (cont’d) Assurance that students’ intellectual property is protected Employment of students at faculty member’s company  Salary must be commensurate with tasks performed Students/staff cannot perform work on University time or use University resources related to a faculty member’s outside professional activities (e.g., providing administrative assistance with faculty’s outside consulting activities)

42. Proper use of students/staff by faculty members with outside interests (cont’d) Reporting of troublesome COI issues by students/staff  to department chair, dean, school’s representative in the Graduate and Professional Student Assembly and/or the COI Office, or  AlertLine, 1-866-858-4456: anonymous, 24 hours a day, accessible from any North American telephone.

43. University Level COI Management: Research Protocols The COIC is responsible for managing potential conflicts involving the following:  Human subject research (IRB)  Animal research (IACUC)  Research and Clinical Training on Decedents (CORID)  Recombinant DNA research (IBC)  Human stem cell research (hSCRO)

44. University Level COI Management: Research Protocols (cont’d) COI questions appear on all research protocol applications  Apply to all individuals listed on protocol Referred to COI Office for review & management

45. University-level COI Management— Licensed Start-up Companies The COI Committee is responsible for managing potential conflicts involving Licensed Start-up Companies  Not publicly-traded  Have an option or license to University intellectual property  University and/or University employees or students, members of their immediate families hold equity (including stock options) Special restrictions on relationships with these companies

46. University-level COI Management —Purchasing University Purchasing Services refers issues to the COI Office for review; e.g., if the requestor or approver of a Directed/Sole Source form has a financial relationship with the company from which a purchase is being requested Purchasing Services reports quarterly to the COIC on purchases made from companies in which University employees have a financial interest

47. University-level COI Management —Office of Research University must attest that the PI of a grant has a current COI disclosure on file; grants administrators query COI database  Research coordinators can check before submission Contracts officers query the database to see whether PI or other investigators have disclosed a relationship with an industry sponsor  If yes, refer to COI Office for review & management

48. Additional Help with COI Management Conflict of Interest Office COI Web site www.coi.pitt.edu www.coi.pitt.edu  includes sample management plans, oversight checklist for supervisors, COI-related forms, and links to relevant policies, the Superform system, and the annual COI memo from the provost and the executive vice chancellor  SOHS Industry Relationship Policy Request specially tailored COI presentations for your department

49. Questions?

50. Contacts/Info/Assistance Jerome L. Rosenberg, PhD Chair/COI Committee 412-624-3007 jrosenb@pitt.edujrosenb@pitt.edu David T. Wehrle, CPA, CFE, CIA Director/COI Office 412-383-1774 wehrledt@upmc.eduwehrledt@upmc.edu Khrys X. Myrddin Associate Director/COI Office 412-383-2828 myrddink@upmc.edumyrddink@upmc.edu Hannelore N. Rogers, MA Coordinator/COI Office 412-383-1968 rogershn@upmc.edurogershn@upmc.edu COI Web site: www.coi.pitt.eduwww.coi.pitt.edu