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 COI Office David Wehrle, Director Khrys Myrddin, Associate Director January 9, 2009

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. ATLANTA JOURNAL CONSTITUTION Depression expert at Emory pulls out of research projects NIH freezes grant money; Emory to begin monitoring potential conflicts of interest Gayle White, Craig Schneider  Tuesday, October 14, 2008 Emory psychiatry professor D. Charles B. Nemeroff is stepping down from university research projects funded by the National Institutes of Health, as the federal agency cracks down on the school’s handling of potential conflicts of interest, university officials said. The NIH has frozen funds for a $9.3 million project on depression led by Nemeroff, acknowledged Ron Sauder, a university vice president. The project had been under way for two of its proposed five years.

14. NEW YORK TIMES Researchers Fail to Reveal Full Drug Pay By GARDINER HARRIS and BENEDICT CAREY June 8, 2008 A world-renowned Harvard child psychiatrist whose work has helped fuel an explosion in the use of powerful antipsychotic medicines in children earned at least $1.6 million in consulting fees from drug makers from 2000 to 2007 but for years did not report much of this income to university officials, according to information given Congressional investigators. By failing to report income, the psychiatrist, Dr. Joseph Biederman, and a colleague in the psychiatry department at Harvard Medical School, Dr. Timothy E. Wilens, may have violated federal and university research rules designed to police potential conflicts of interest, according to Senator Charles E. Grassley, Republican of Iowa. Some of their research is financed by government grants.

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 • hSCRO • Industry Relationship Policy (SOHS/UPMC) • Annual COI memo from the provost & executive vice chancellor (Directive to Disclose) Note: a new COI Policy is scheduled to be implemented in 2009

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 includes 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. 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

25. 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

26. 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

27. 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

28. 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

29. 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

30. 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

31. COI Management Strategies (cont’d) • 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

32. 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 acknowledging that they have been informed • Students/staff should discuss any concerns with faculty members’ non-conflicted supervisor and/or COI Committee

33. 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

34. 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 is 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 respect to faculty’s outside consulting activities)

35. Proper use of students/staff by faculty members with outside interests (cont’d) • Reporting of troublesome COI issues • 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.

36. 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

37. 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)

38. 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 …….

39. 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

40. 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 • Human stem cell research

41. Additional Help with COI Management • Conflict of Interest Office • COI Office Web sitewww.coi.pitt.edu • includes sample management plans, case studies, oversight checklist for supervisors, links to relevant policies, and annual COI memo from the provost and the executive vice chancellor (aka: Directive to Disclose)

42. Resources: Learning about COI • COI management presentations tailored to specific departments, upon request • ISER Conflict of Interest Module…

43. ISER Conflict of Interest Module: Who must complete it? • Those who completed Part II of the University’s Faculty/Researcher form and/or those involved in industry-sponsored research are required to complete the ISER COI module (Internet-based Studies in Education and Research, formerly known as RPF modules)

44. Completing the ISER Module • Go to https://cme.hs.pitt.edu/ • click "All Modules" • select "COI Module" from list • Test out of module • Take chapter quizzes • Receive certification

45. Completing the ISER Module (cont’d) • at this time, re-certification is not required (despite the “expired” note that may appear in system) • access to the ISER database for appropriate individuals (to determine whether the COI module was completed) may be requested through Kathy Sidorovich (ksidorovich@hs.pitt.edu)

46. Questions

47. Contacts/Assistance • Jerome L. Rosenberg, PhD/Chair, COI Committee 412-624-3007 jrosenb@pitt.edu • David T. Wehrle, CPA, CIA, CFE/Director, COI Office 412-383-1774 wehrledt@upmc.edu • Khrys X. Myrddin/Associate Director, COI Office 412-383-2828 myrddink@upmc.edu • Hannelore Rogers, MA/Coordinator, COI Office 412-383-1968 rogershn@upmc.edu • COI Web site: www.coi.pitt.edu • iTarget Team: 412-648-2222 for technical assistance with Superform system