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

2. NEW REVISED CONFLICT OF INTEREST POLICY, USING THE SUPERFORM, & FINANCIAL COI MANAGEMENT COI Office David Wehrle, Director Khrys Myrddin, Associate Director October 13, 2010

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  Consultant/speaker 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. K. C. Stengel developed a new method for collecting adult stem cells, which was patented by the University; she receives royalties for this IP through Pitt  The technology is licensed to Cell Colonies, Inc., a non-public company  She holds equity in the company  Dr. Stengel 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 New University COI Policy 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. 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 List of changes and policy flow charts are also available from the COI website:  http://www.coi.pitt.edu/Policies/index.htm http://www.coi.pitt.edu/Policies/index.htm

14. Rationale for a Conflict of Interest (COI) Policy Our COI Policy reaffirms the value of faculty members interactions with the commercial sector and provides guidelines for maintaining integrity in research in the course of such interactions.

15. How rev. COI policy 11-01-03 differs from previous version Policy 11-02-03 Commercialization of Inventions Through Independent Companies merged into 11-01- 03  Eliminates the “Entrepreneurial Oversight Committee” as a separate entity; duties assumed by COIC “EOC Companies”  Licensed Start-Up Companies Elimination of the 1% of salary threshold for disclosing outside remuneration Definition of a zero-threshold for individually-held equity in determining a Significant Financial Interest (SFI) in any non-public company

16. How rev. COI policy differs from previous version (cont’d) Codification of “Working COI Policies” and procedures for protocols overseen by regulatory committees (IRB, IACUC, etc.) Explicit statement of the PI exclusion rule for specifically regulated research Explicit rules governing exemptions from the PI exclusion rule

17. How rev. COI policy differs from previous version (cont’d) Inclusion of a community member on COI Committee and on a data stewardship committee for a project sponsored by a company in which the University holds equity and a conflicted investigator is allowed to be PI Increase in the equity cap in Licensed Start-up Companies from 20% to up to 49% Assuming his/her department chair does not object, a researcher conflicted with a Licensed Start-up Company can be PI on the University’s portion of an SBIR or STTR grant not involving human subjects or animals, subject to implementation of appropriate COI management plan.

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

19. 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”

20. Annual COI Filing Process: Who? (cont’d) Designated Administrator/Staff form  Employees classified as Administrator IV or above, and 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) Deans, department chairs, division chiefs, and center directors with faculty appointments must complete both University forms.

21. 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

22. What is the Superform system? The electronic Superform system 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.htmhttp://compliance.infonet.upmc.com/COI.htm

23. 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

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

25. 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 no links to forms appear on Welcome screen, add University affiliation to profile

26. 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 Print and sign Signature Page (SP)

27. Making disclosures—Using the Superform system (cont’d) 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

28. COI Oversight by Supervisors Faculty/Researcher—Department Level Department Chairs review Faculty/Researcher disclosures  Ensure that all required employees have signed and submitted the Signature Page by April 15

29. COI Oversight by Supervisors Faculty/Researcher—Department Level (cont’d) Prepare Management Reporting Forms (MRF) for individuals who disclosed outside interests  Section E: 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? 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

30. COI Oversight by Supervisors Faculty/Researcher—Department Level (cont’d)  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.

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 Supervisor reviews Designated Administrators/Staff disclosures  Ensures that all required employees have signed and submitted the SP by April 15  The 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;  SPs and management plans of resolved conflicts need not be forwarded, and should be filed in 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  Consultancies, speaking engagements, and membership on scientific advisory boards 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  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

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 department chair or dean Formal notification of faculty members’ interest in an outside company  Faculty members should distribute Student/Staff Notification Form for signature by students/staff  Students/staff should discuss any concerns with faculty members’ non-conflicted supervisor and/or COI Committee

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 Conflict of Interest Committee, 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. COI questions that appear on protocol applications apply to all investigators and research personnel PI is responsible for ensuring that all investigators and study personnel review these questions Reporting must be kept current  Whenever new outside interests are accrued, investigators should notify the COI Office and the appropriate regulatory committee (e.g., IRB, IACUC, etc.), and update their Faculty/Researcher forms. University-level COI Management— Research Protocols (cont’d)

45. COI Questions on Protocols Does the principal investigator or any co-investigator or research coordinator involved in this study (or in aggregate with his/her spouse, dependents or other members of his/her household): a. possess an equity interest in the publicly-traded entity that either sponsors this research or owns the technology being evaluated that exceeds 5% ownership interest or a current value of $10,000? b. possess any equity interest in the non-publicly-traded entity that either sponsors this research or owns the technology being evaluated?

46. COI Questions on Protocols (cont’d) c) receive salary, consulting fees, honoraria, royalties or other payments from the entity that either sponsors this research or owns the technology being evaluated that is expected to exceed $10,000 in any twelve-month period? d) have rights to the intellectual property (IP) being evaluated, as either the inventor of the IP for which a patent has been issued, or as the inventor of the IP that has been optioned or licensed to a company? e) have a financial relationship with a Licensed Start- up Company (which is being monitored by the COI Committee) that has an option or license to utilize the technology being evaluated?

47. IRB only f. Receive compensation of any amount when the value of the compensation would be affected by the outcome of the research, such as compensation that is explicitly greater for a favorable outcome than for an unfavorable outcome or compensation in the form of an equity interest in the entity that either sponsors this research or owns the technology being evaluated. COI Questions on Protocols (cont’d)

48. Answering “Yes” to any of the COI questions on the IRB protocol requires use of the Standard COI Management Plan (SMP) for Human Subject Research  Available in OSIRIS or from the COI Office Web site: http://www.coi.pitt.edu/Forms/StandardCOIMgmtPlan- HSR.htm http://www.coi.pitt.edu/Forms/StandardCOIMgmtPlan- HSR.htm University COI Management—Research Protocols (cont’d)

49. For IACUC, CORID, and hSCRO, investigator cannot be PI if s/he answers “Yes” to the questions asking about equity, remuneration, or a relationship with a Licensed Start-up company.  Management plan similar to SMP, less the items specific to HSR  IBC did not adopt the PI-exclusion rule; reviewed on a case-by-case basis Financial relationships only in the IP being evaluated are reviewed on a case-by-case basis. University COI Management— Research Protocols

50. University-level COI Management— Licensed Start-up Companies The COI Committee is responsible for managing potential conflicts involving Licensed Start-up Companies (i.e., not publicly traded)  that have an option or license to University intellectual property  in which equity (including stock options) is held by University employees or students, members of their immediate families, or by the University Special restrictions on relationships with these companies

51. 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

52. 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 Contracts officers query the database to see whether PI or other investigators have disclosed a relationship with an industry sponsor  If yes, referred to COI Office for review & management

53. Additional Help with COI Management Conflict of Interest Office COI Office Web site www.coi.pitt.eduwww.coi.pitt.edu  includes sample management plans, case studies, 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

54. Questions?

55. Contacts/Assistance Jerome L. Rosenberg, PhD Chair/COI Committee 412-624-3007 jrosenb@pitt.edu jrosenb@pitt.edu David T. Wehrle, CPA, CFE, CIA Director/COI Office 412-383-1774 wehrledt@upmc.edu wehrledt@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.edu www.coi.pitt.edu