University of Pittsburgh

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

2. COI RESPONSIBILITIES FACULTY/STAFF DEVELOPMENT PROGRAM Annual COI Filing Process & Revised PHS COI Regulations COI Office: David Wehrle, Director Khrys Myrddin, Associate Director Benjamin West, Compliance Coordinator March 28, 2013

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 • 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.

6. Examples of Potential Conflicts(cont’d) Example 3 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

7. 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;

8. 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; scandals or negative media attention may occur.

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

10. Today’s topics(cont’d) • University-level COI Management • Research protocols • Entrepreneurial endeavors • Purchasing • PHS Final Rule

11. Annual COI Filing Process • Annual COI memo from the provost & executive vice chancellor • University Policies • 07-05-02 • 11-01-03

12. Annual COI Filing Process: Who? • Faculty/Researcher Forms (“Regular” & PHS-funded) • All full-time faculty members • Staff & students 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.

13. Annual COI Filing Process: Who?Cont’d • “Regular” University of Pittsburgh Faculty/ Researcher Form: all faculty members, as well as others in any position, including students and staff, who direct or can materially influence research, or who are responsible for the design, conduct, and reporting of research that isnot funded by any operating division of the Public Health Service (PHS), such as the National Institutes of Health. • PHS-Funded University of Pittsburgh Faculty/Researcher Form: anyone participating in the design, conduct, or reporting of any research funded by any agency of the Public Health Service, such as NIH, AHRQ, FDA, CDC, you must complete this form)

14. Annual COI Filing Process: Who?(cont’d) • Designated Administrator/Staff Form • Deans, department chairs, division chiefs, and center directors; • Employees classified as Administrator IV or above; • 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);

15. 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 systemhttps://coi.hs.pitt.edu

16. The Superform system COI disclosures must be filed electronically (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 the University of Pittsburgh only.

17. Pitt/UPMC Employees • Employees with appointments at UPMC/UPP must use the UPMC COI system in MyHUB to fulfill their UPMC COI reporting requirements. • MyHUB is not able to generate University COI disclosure forms at this time; • developing a joint form to fulfill both institutions’ COI reporting requirements • ready by the end of 2013 • To access the UPMC COI system, log into MyHUB, select the Human Resources tab and click the COI link under My Profile.

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

19. Who Has Access to the COI database?(cont’d) • Request access through the COI Office (provide name, HSConnect username, departmental affiliation, and level of access to be granted, i.e., Basic or Operational); Operational access must be approved by department chair. • Send request for access to rogershn@upmc.edu • Research administrators with Basic access can determine whether investigators have a current COI form on file.

20. 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

21. 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)

22. 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.

23. COI Oversight by SupervisorsFaculty/Researcher—Department Level • Ensure that all required individuals have signed and submitted a Signature Page by April 15 • Department Chairs & Directors review Faculty/ Researcher forms received; • Prepare Management Reporting Form (MRF) for each individual who disclosed outside interests, identifying COIs and explaining how they were managed. • Use same MRF for both Faculty/Researcher forms (“regular” and PHS-funded)

24. COI Oversight by SupervisorsFaculty/Researcher—Department Level (cont’d) • Management Reporting Form (MRF) • Used to document all actions that have been taken to manage identified conflicts of interest.

25. COI Oversight by SupervisorsFaculty/Researcher—Department Level(cont’d) • Instructions for completing MRF • Identify faculty member and supervisor • Do not re-enter detailed responses from Faculty/Researcher Form, because this form accompanies the Signature Page • Enter only the category of financial interest (e.g., ownership interests, offices & positions, remunerative activities, outside employment of students/staff, technology transfer activities, etc.)

26. COI Oversight by Supervisors Faculty/Researcher—Department Level(cont’d) • Briefly describe all actions taken/or that will be taken to manage any COIs between an individual’s responsibilities at Pitt and his/her outside financial interests.

27. COI Oversight by Supervisors Faculty/Researcher—Department Level (cont’d) • If no management is needed, provide a justification (e.g., individual does not conduct research sponsored by, or of commercial interest to, the company; individual makes no purchasing decisions, etc.)

28. COI Oversight by SupervisorsFaculty/Researcher—Department Level(cont’d) • Complete departmental Annual Data Summary Report • Submit only Signature Pages disclosing outside interests, the related signed MRFs, and department’s Annual Data Summary Report to dean or regional campus president for review • Keep Signature Pages with no reported outside interests on file in unit for seven years.

29. COI Oversight by SupervisorsFaculty/Researcher—Dean’s/Regional Campus President’s Level • Dean/Regional campus president • reviews forms received from chairs/directors • Approves or modifies MRFs, as necessary • prepares the unit’s (e.g., school or regional campus) Annual Data Summary Report for Faculty/Researcher COI Forms • submits departmental Annual Data Summary Reports, Signature Pages, MRFs received from all departments in unit and the unit’s Annual Data Summary Report to the provost or senior vice chancellor for the health sciences • due by May 15.

30. COI Oversight by SupervisorsDesignated Administrators/Staff—Department Level • Ensure all required employees have signed and submitted Signature Pages by April 15, 2013; • Review printed Signature Pages received • Develop a COI management plan, as needed • Document the plan and employee’s agreement to it in the form of a memorandum (do not use the MRF); keep this on file in unit; do not forward to next higher supervisor unless requested. • Prepare and submit an Annual Data Summary Report for Designated Administrator/Staff COI Forms to the next higher reporting authority within the responsibility center (list number of disclosures submitted and number that disclosed outside interests or activities). • Due May 15, 2013

31. COI Oversight by Supervisors Designated Administrators/Staff—Department Level (cont’d) • 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 • Signature Pages and management plans of resolved conflicts should not be forwarded, but should be filed in the 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 • All outside professional activities (consultancies, speaking engagements, scientific advisory boards); • 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 on the average. • Note: staff members must conduct all outside activities on their own time.

34. Departmental COI Management (cont’d) • Department chairs are responsible for the development of COI management plans for research not overseen by the IRB or IACUC. • Chairs may contact the COI Office for assistance; • COI Office appreciates receiving a copy of the management plans for our records.

35. 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.

36. Proper use of students/staff by faculty members with outside interests • Prospective review and approval of activities by students’ department chairs or deans • 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;

37. 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 • 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;

38. 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.

39. University Level COI Management: Research Protocols • The Conflict of Interest Committee (COIC) is responsible for managing potential conflicts involving research overseen by the IRB and IACUC.

40. University Level COI Management: Research Protocols(cont’d) • COI questions appear in all research protocol applications and apply to all Investigators listed in the protocol • Referred to COI Office for review & management

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

42. University-level COI Management —Purchasing • University Purchasing Services refers issues to the COI Office for review; e.g., if the individual completing 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 COI Committee on purchases made from companies in which University employees have a financial interest.

43. 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 to verify compliance; • Contract officers also query the database to determine whether PI or other investigators have disclosed a relationship with an Industry sponsor • If yes, matter is referred to COI Office for review & management

44. Revised Public Health Service Regulations: Major Changes • Definitions • SFI/Significant Financial Interest: a financial interest exceeding established thresholds that reasonably appears to be related to the Investigator’s institutional responsibilities • FCOI/Financial Conflict of Interest: an SFI that could directly and significantly affect the design, conduct, or reporting of PHS-funded research

45. Revised Public Health Service Regulations: Major Changes (cont’d) • Reporting thresholds have decreased; • reimbursed or sponsored travel expenses exceeding $5,000 in a 12 month period must be reported and evaluated; • Publicly accessible Web site disclosing FCOIs; • COI training at least every 3 years.

46. Revised Public Health Service Regulations: Major Changes (cont’d) • “Relatedness” assessment • Department chairs will need to review SFIs between $5,000 -$10,000 to determine whether they constitute an FCOI with PHS-funded research. • COIC will review and make final FCOI determination for SFIs greater than $10,000.

47. Revised Public Health Service Regulations: Major Changes (cont’d) • Management of FCOIs • For FCOIs in the $5,000-$10,000 range, department chairs will determine level of COI management; • For FCOIs over $10,ooo centralized management proceeds as normal.

48. PHS COI Reviews—Office of Research • Submission stage: the Office of Research will check that PI/PD and all Senior/Key personnel have PHS Faculty/Researcher forms on file & have completed the CITI PHS COI Training module. • Award stage: Office of Research check COI PHS Faculty/Researcher forms of key personnel for SFIs • Positive responses referred to COI Office for review • COI Office contacts Investigator to obtain supervisor’s review • Depending on nature of SFI, supervisor review may be final, or COI Committee will review • If supervisor and/or COIC determines that there is no FCOI, COI Office informs the Office of Research that funds can be released.

49. Office of Research PHS Reviews cont’d • If there is an FCOI, Investigator must agree to a management plan before funds can be released • COI Office reports managed FCOI to funding agency • Public accessibility • As required by the revised PHS regulations, managed FCOIs must be posted on a publicly-accessible Web site of the institution, listing • Date Disclosed • Investigator with FCOI • Title • PHS Funding: • Role on Research Project • Name of Entity in which Significant Financial Interest (SFI) is held • Nature of the SFI • Approximate dollar value of the SFI

50. Additional Help with COI Management Conflict of Interest Office COI Web sitewww.coi.pitt.edu includes 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