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. The WHYs & HOWs of Financial Conflict of Interest Management Khrys Myrddin Associate Director, COI Office March 25, 2008

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

9. 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;

10. 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.

11. 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….

12. FDA Halts Gene Experiments at University of Pennsylvania By Rick Weiss and Deborah NelsonWashington Post Staff WritersSaturday, January 22, 2000; Page A1 The federal government yesterday halted all human gene therapy experiments involving a prominent researcher at the University of Pennsylvania, saying an investigation into the September death of a teenager there found the school's prestigious program in serious disarray.

13. THE CHRONICLE OF HIGHER EDUCATION Thursday, April 14, 2005Former Professor Pleads Guilty to Embezzling Nearly $1-Million in Federal Grants Thursday, April 21, 2005George Washington U. to Pay $1.8-Million to Avoid Prosecution in Embezzlement Case

14. December 4, 2006 • NIH Scientist Charged in Connection with Pfizer Consulting

15. Disclosure: Why? • University Policies • 11-01-03 (COI – Research/Teaching) • 07-05-02 (COI – Designated Administrators and Staff) • COI Committee Working COI Policies • IRB • IACUC • CORID • ESCRO • Industry Relationship Policy (SOHS/UPMC) • Annual COI memo from the provost & executive vice chancellor (Directive to Disclose)

16. Disclosure: Who? • Faculty/Researchers • Employees classified as staff, who direct or can materially influence research, or who are responsible for the design, conduct, and reporting of research

17. Disclosure: Who? (cont’d) • Employees classified as Administrator IV or above, and those of other classifications 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)

18. Reporting Financial Relationships • 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 Superform system contains reporting forms for the University of Pittsburgh, the UPMC, and the University of Pittsburgh Physicians. • All forms filed become part of a secure COI database, accessible only to authorized individuals.

20. Who Uses 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 Uses the COI Database?(cont’d) • Research administrators can determine whether investigators have a current COI form on file by using the Administrative Access Gateway • Administrative access may be requested through the COI Office (requires name, HS Connect e mail address & departmental affiliation of individuals eligible to have access)

22. Using the Superform system • Create an HSConnect account/use an existing account • Retrieve forgotten password • Create/update your profile • Describe University affiliation • Indicate which COI forms must be filed • Change e-mail address/password

23. Using the Superform system(cont’d) • Answer Part I Questions • Answer Part II Questions (as appropriate) • Review and file disclosure • 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. Faculty/Researcher formPart I • Question 1 Ownership Interests • During the past calendar year, did you or members of your immediate family, own or control an equity interest in any organization in your field of academic interest or specialization that when aggregated for you, your spouse and dependent children exceeded a 5% ownership interest or is greater than $10,000?

25. Faculty/Researcher formPart I • Question 2 Offices and Positions • During the past calendar year, were you or a member of your immediate family, a director, officer, partner, employee, or agent, or in any managerial position in any organization outside the University of Pittsburgh that might be affected by your research or administrative activities? (does not apply to governmental committees, community, political, academic, charitable, religious, social or professional nonprofit organizations.)

26. Faculty/Researcher formPart I • Question 3 Remunerative Activities • Does income (cash or in-kind, other than reimbursement of reasonable expenses) related to your teaching, research, or administrative activities received by you during the past year or expected over the coming year from any one organization outside the University exceed 1% of your University salary, or does income aggregated for you, your spouse, and dependent children received from such an organization during the past year or expected over the coming year exceed $10,000?

27. Faculty/Researcher formPart I • Question 4 Outside Employment of Students or Staff • Do you now, or did you during the past calendar year, employ any of your students or staff in a company or organization outside the University?

28. Faculty/Researcher formPart I • Question 5 Technology Transfer Activities • Are you or a member of your immediate family the inventor of any technology for which an invention disclosure has been filed or which is being developed or evaluated in connection with your research activities?

29. Faculty/Researcher formPart I • Question 6 Other Transactions or Facts • During the past calendar year, did you or any member of your immediate family have an interest in any contract, sale, or other transaction to which the University of Pittsburgh or one of its affiliates was a party, or are there other situations, not listed above, that you believe may create an actual or perceived conflict of interest?

30. Faculty/Researcher form Part II • Part II • Details must be provided to explain any positive responses provided in Part I by describing the nature of the outside interest.

31. Faculty/Researcher form Part II • Question 7 Federally supported research • If you answered Yes to Question 1 or, under certain circumstances, to Question 3 , answer the following: • Do you have, or have you had within the past twelve months, federally supported research that might reasonably appear to affect a company in which you have an interest?

32. Faculty/Researcher form Part II • Question 8 Industry supported research • If you answered Yes to Questions 1, 2, or 3, answer the following question. • Do you have, or have you had within the past twelve months, industry supported research that might reasonably appear to affect a company in which you have an interest?

33. Designated Administrator/Staff form Part I (cont’d) • Question 1 Offices and Positions • Are you, your spouse, your registered domestic partner or a dependent child an officer, director, trustee, partner (general or limited), employee or regularly retained agent of any organization with which (a) the University has had business dealings during the past year, or (b) there is a reasonable possibility the University may in the next year have business dealings?

34. Designated Administrator/Staff form Part I (cont’d) • Question 2 Ownership Interests • Do you, your spouse, your registered domestic partner or a dependent child, individually or in the aggregate, have the actual or beneficial ownership of stock, equity, debt or any other financial interest (other than a Permitted Interest as defined in the policy) in any organization with which (a) the University has had business dealings during the past year, or (b) there is a reasonable possibility the University may in the next year have business dealings?

35. Designated Administrator/Staff form Part I (cont’d) • Question 3 Remunerative Activities • Does remuneration for services (other than salary as an employee) received during the past year or expected over the coming year aggregated for you, your spouse, and dependent children exceed $500 from any one organization with which (a) the University has had business dealings during the past year, or (b) there is a reasonable possibility that the University may in the next year have business dealings?

36. Designated Administrator/Staff form Part I (cont’d) • Question 4 Other Transactions • Do you have any other interest, relationship or transaction that has in the past year created, or reasonably could in the next year create, a real, apparent or potential conflict of interest contrary to the spirit or general principles set forth in the University’s Conflict of Interest Policy for Designated University of Pittsburgh Administrators and Staff (e.g., a proposed University transaction with a nephew, even though a nephew is not included in the definition of “Related Person”)?

37. Designated Administrator/Staff form Part I (cont’d) • Part II • Details must be provided to explain any positive responses provided in Part I by describing the nature of the outside interest.

38. COI Oversight by SupervisorsFaculty/Researcher—Department Level • Department Level • Review of Faculty/Researcher disclosures • Ensure that all required employees have submitted and signed the Signature Page (SP) by April 15

39. COI Oversight by Supervisors Faculty/Researcher—Department Level, cont’d • Prepare a Management Reporting Form (MRF) or electronic MRF (eMRF) for those individuals who disclosed outside interests • Prepare departmental Annual Data Summary report on disclosures submitted • 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

40. COI Oversight by Supervisors Faculty/Researcher—Dean’s Level • Dean’slevel • Review forms received from chairs • Approve or modify any MRFs, as necessary • Prepare School’s Annual Data Summary report • Submit Signature Pages, Management Reporting Forms, and Departments’ and School’s Annual Data Summary Reports to the provost or senior vice chancellor for the health sciences by May 15

41. COI Oversight by SupervisorsDesignated Administrators/Staff—Dept. Level • Review of Designated Administrators/Staff disclosures • Ensure that all required employees have submitted and signed a 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) • Prepare a brief annual summary of disclosures made, and submit it to the next higher reporting authority within the responsibility center

42. COI Oversight by SupervisorsDesignated Administrators/Staff—Dept. Level • Report unresolved conflicts to the provost, senior vice chancellor for 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

43. 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

44. COI Management Strategies • Required prospective approval from dean or department chair for • Consultancies, participation in speakers bureaus, 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

45. COI Management Strategies • 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

46. COI Management involving Start-up Companies • The Entrepreneurial Oversight Committee is responsible for managing potential conflicts involving start-up companies (i.e., they are 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

47. Transactional Reporting • 4 COI questions appear on protocol applications • 4 COI questions 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 (i.e., whenever new outside interests are accrued, a revised disclosure must be made)

48. 4 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? [] Yes [] No 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? [] Yes [] No …….

49. 4 COI Questions on Protocols (cont’d) c. have an agreement with the University or an external entity that would entitle sharing current or future commercial proceeds related to the technology being evaluated (e.g., royalties through a license agreement)? [ ] Yes [ ] No d. have a financial relationship with a start-up company (which is being monitored by the Entrepreneurial Oversight Committee) that has an option or license to utilize the technology being evaluated? [ ] Yes [ ] No

50. COI Management Involving Specifically Regulated Research • The COIC is responsible for managing potential conflicts involving the following: • Human subject research overseen by the IRB • Invocation of the COI Committee’s Standard COI Management Plan, as appropriate • http://www.coi.pitt.edu/forms/StandardCOIMgmtPlan-HSR.doc • Animal research overseen by the IACUC • Research on the clinically brain-dead (CORID) • Recombinant DNA research • Embryonic stem cell research