F S D P W o r k s h o p

1. F S D P W o r k s h o p University of Pittsburgh Conflict of Interest OfficeA Partner in Promoting Integrity in Research, Teaching, and Administration

2. INTRODUCTION TO THE SUPERFORM SYSTEM & FINANCIAL CONFLICT OF INTEREST MANAGEMENT COI Office David Wehrle, Director Khrys Myrddin, Associate Director April 2, 2010

3. What is a Conflict of Interest? • A potential Conflict of Interest (COI) 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. Maryann Ruecken developed a back brace, which was patented by the University; she receives royalties for the device through Pitt • The technology is licensed to Strait & Narrow, Inc., a non-publicly held company • She holds equity in the company • Dr. Ruecken is conducting federally sponsored research to further evaluate the technology.

8. Examples of Potential Conflicts(cont’d) • Example 5 • Dr. Argus Hawkeye invented forceps for micro surgery of the eye; • This device was licensed to Rod & Cone Corp by the University; • Dr. Hawkeye has a right to licensing income (royalties) for the device through Pitt; • Dr. Hawkeye wishes to be PI on a clinical trial to further develop the forceps.

9. Importance of COI Management Why is it important to identify and manage conflicts of interests?

10. Importance of COI Management(cont’d) 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 academic science;

11. Importance of COI Management(cont’d) • product or service may be inferior; • price may be too high; • may give actual or perceived improper preferential treatment to vendors; • may violate terms of research grants and contracts (including failure to disclose COI) and federal regulations.

12. 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….

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

14. Today’s topics (cont’d) • University-level COI Management • Research protocols • Entrepreneurial endeavors • Purchasing • Office of Research • Additional Help with COI/Resources

15. Annual COI Filing Process • University Policies • 11-01-03 (COI – Research/Teaching) • 07-05-02 (COI – Designated Administrators and Staff) • Annual COI memo from the provost & executive vice chancellor Note: A new University COI policy has just been signed by the Chancellor.

16. Annual COI Filing Process: Who? • Faculty/Researcher Form • All individuals with regular faculty appointments • Employees who direct or can materially influence research, or who are responsible for the design, conduct, and reporting of research

17. 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.

18. 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

19. 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.htm

20. 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

21. 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.edu

22. 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

23. 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)

24. 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

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

26. COI Oversight by SupervisorsFaculty/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

27. COI Oversight by SupervisorsFaculty/Researcher—Department Level (cont’d) • Answer No if any relationship requires COI management; 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.

28. COI Oversight by SupervisorsFaculty/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

29. COI Oversight by SupervisorsFaculty/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 Monday, May 17, 2010

30. COI Oversight by SupervisorsDesignated 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) • Prepares a brief memo summarizing disclosures made, and submits it to the next higher reporting authority within the responsibility center

31. COI Oversight by SupervisorsDesignated Administrators/Staff—Department Level • Report unresolved conflicts to the provost, senior vice chancellor for the health sciences, or executive vice chancellor by Monday, May 17; • SPs and management plans of resolved conflicts need not be forwarded, and should be filed in department

32. 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

33. 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

34. 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 • Establishment of an oversight committee • Dilution of investigator’s role in study, i.e., cannot be PI, but may be co-investigator

35. 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

36. 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

37. Proper use of students/staff by faculty members with outside interests (cont’d) • Assurance that students’ inventions remain property of University • 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)

38. 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.

39. SOHS/UPMC Industry Relationship Policy • Covers interactions between faculty/ staff in the Schools of the Health Sciences and representatives of the pharmaceutical, biotechnology, medical device, and hospital equipment supply industry (“Industry”) • Bans gifts & meals • Prohibits participation in “Speakers Bureaus” • Defines criteria for participation at off-site meetings

40. SOHS/UPMC Industry Relationship Policy (cont’d) • Imposes certain requirements on consulting contracts • Compensation must be tied to specific deliverables (i.e., no flat rate per month) • Contracts for more than $10K/12 months must be approved by office of Senior Vice Chancellor for the Health Sciences, Dr. Arthur Levine

41. University-level COI Management—Research Protocols • The COIC is responsible for managing potential conflicts involving the following: • Human subject research overseen by the IRB • Animal research overseen by the IACUC • Research on the clinically brain-dead (CORID) • Recombinant DNA research (rDNA/IBC) • Human stem cell research (hSCRO)

42. COI questions appear on protocol applications; apply to PI, Co-Is, and research coordinators PI is responsible for ensuring that all Co-Is and research coordinators answer these questions Reporting must be kept current Whenever new outside interests are accrued, faculty members 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)

43. 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 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. receive salary, royalty or other payments from the entity that either sponsors this research or owns the technology being evaluated that is expected to exceed $10,000 per year? …….

44. COI Questions on Protocols (cont’d) c. 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? d. have a financial relationship with a Licensed Start-up Company that has an option or license to utilize the technology being evaluated?

45. COI Questions on Protocols (cont’d) • IRB only e. 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.

46. University COI Management—Research Protocols • Answering Yes to any of the questions on the IRB protocol requires use of the Standard COI Management Plan (SMP) for Human Subject Research • Available w/in OSIRIS and from the COI Office Web site: http://www.coi.pitt.edu/Forms/StandardCOIMgmtPlan-HSR.htm

47. University COI Management—Research Protocols • For IACUC, CORID, and hSCRO, investigator cannot be PI if s/he answers Yes to the questions asking about equity, remuneration, or a relationships with a 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.

48. University-level COI Management—Licensed Start-up Companies • The COI Committee is responsible for managing potential conflicts involving start-up companies (i.e., not publicly traded) • that have an option or a license for 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 individual relationships with these companies

49. 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 licensed start up companies

50. 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 • Refer to COI Office for review & management