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

2. Annual COI Filing Process FACULTY/STAFF DEVELOPMENT PROGRAM COI Office: Khrys Myrddin, Associate Director Benjamin West, Compliance Coordinator February 12, 2014

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.  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.  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.  Departmental responsibilities ◦ Annual COI filing process ◦ Using the Superform system ◦ Using the Pitt/UPMC Joint COI questionnaire ◦ COI Oversight & Management

10.  University-level COI Management ◦ Research protocols ◦ Entrepreneurial endeavors ◦ Purchasing

11.  Annual COI memo from the provost & executive vice chancellor – February 15 th  University Policies ◦ 07-05-02 ◦ 11-01-03

12.  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 not conducting research.

13. ◦ “Regular” 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 is not funded by an agency of the Public Health Service (PHS) ◦ PHS 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, must complete this form

14.  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.  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  electronically using the Superform system https://coi.hs.pitt.edu directly or by completing the Pitt/UPMC Joint COI questionnaire in MyHub https://coi.hs.pitt.edu

16. The Superform system  COI disclosures must be filed electronically (there are no paper forms).  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.  University faculty with appointments at UPMC/UPP should use the Pitt/UPMC Joint COI questionnaire in My HUB to fulfill their UPMC and Pitt COI reporting requirements  Data entered in the My HUB questionnaire is transferred to Pitt’s COI database and used to generate University COI disclosure forms in the Superform system

18.  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.  Request access through the COI Office (provide name, HSConnect username, departmental affiliation, and level of access to be granted, i.e., Basic or Operational) ◦ Send request for access to westbt@upmc.eduwestbt@upmc.edu  Research administrators with Basic access can determine whether investigators have a current COI form on file  Operational access allows administrator to see details of financial disclosures ◦ Must be approved by department chair

20.  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.  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.  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.  To access the UPMC COI system, log into My HUB, select the Human Resources tab and click the COI link under My Profile;My HUB  Select “UPMC Pitt Joint Form,” and then answer the subsequent questions to indicate which University forms to complete ◦ “Regular” OR PHS Faculty/Researcher form ◦ Designated Administrator/Staff form, if applicable

24.  After submitting their answers, users will be prompted to log into the Superform system with their HSConnect username and password and taken to the “Filing History” tab where the newly-created form(s) are highlighted in green. ◦ Print the form to sign and submit to supervisor.  For assistance: ◦ Check My HUB Frequently Asked QuestionsMy HUB Frequently Asked Questions ◦ ISD Help Desk at 412-647-HELP (4357)

25.  Faculty/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.

26.  Management Reporting Form (MRF) ◦ Used to document all actions that have been taken to manage identified conflicts of interest.

27.  Instructions for completing MRF ◦ Do not re-enter detailed responses from Faculty/Researcher Form ◦ Enter only the category of financial interest (e.g., ownership interests, offices & positions, remunerative activities, outside employment of students/staff, technology transfer activities, etc.)

28. ◦ 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. ◦ 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.)

29.  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.

30.  Dean/Regional campus president ◦ reviews forms received from chairs/directors o 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 th

31.  Ensure all required employees have signed and submitted Signature Pages by April 15th  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 th

32.  Report unresolved conflicts to the provost, senior vice chancellor for the health sciences, or executive vice chancellor by May 15 th o 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

33.  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

34.  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

35.  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.

36. Department-level 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.

37.  PHS COI Review ◦ The PHS COI regulations require the University to consider whether disclosed SFIs valued above $5,000 could give rise to a Financial Conflict of Interest (FCOI) with any PHS-funded project in which the individual is engaged. ◦ Department chairs are responsible for FCOI determination for SFIs between $5,000 -$10,000  COIC will review and make final FCOI determination for SFIs greater than $10,000.

38.  PHS COI Review – “Relatedness assessment” o Supervisors must determine if an investigator’s SFI is related to any PHS-funded projects on which the individual serves as an investigator 1.Is the work being done under any of the PHS grants or contracts evaluating or developing any of the company’s products or intellectual property? 2.To your knowledge, are any of these PHS-funded research projects evaluating or developing any product of a competitor of the company? 3.Is the company providing funding or other support (e.g., drugs or devices) for any of these PHS-funded projects?

39.  If the answer to any above question is yes, the supervisor needs to determine if the SFI gives rise to an FCOI ◦ i.e., could directly and significantly affect the design, conduct, or reporting of the PHS-funded project.  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.

40.  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

41.  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;

42.  Assurance that students’ intellectual property is protected;  Employment of students at faculty member’s company ◦ Salary must be commensurate with tasks performed.

43.  The Conflict of Interest Committee (COIC) is responsible for managing potential conflicts involving research overseen by the IRB and IACUC.  COI questions appear in all research protocol applications and apply to all Investigators listed in the protocol  Referred to COI Office for review & management

44. University-level COI Management— Licensed Start-up Companies  Licensed Start-up Companies (LSCs) ◦ 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)  The COI Committee is responsible for managing potential conflicts involving LSCs  Special restrictions on relationships with these companies

45.  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.

46.  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

47.  Submission stage: Office of Research checks that PI/PD and all Senior/Key personnel have current PHS Faculty/Researcher forms on file & have completed the CITI PHS COI Training module.  Award stage: Office of Research checks 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.

48.  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  As required by the PHS COI regulations, managed FCOIs are posted on a publicly-accessible website:  http://www.coi.pitt.edu/PHS/FCOIList.htm http://www.coi.pitt.edu/PHS/FCOIList.htm

49. Resources  Conflict of Interest Office  COI website www.coi.pitt.edu www.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

50. Contacts Jerome L. Rosenberg, PhD Chair/COI Committee 412-624-3007 jrosenb@pitt.edujrosenb@pitt.edu David T. Wehrle, CPA, CFE, CIA Director/COI Office 412-383-1774 wehrledt@upmc.eduwehrledt@upmc.edu Khrys X. Myrddin, MPPM Associate Director/COI Office 412-383-2828 myrddink@upmc.edumyrddink@upmc.edu Benjamin T. West, BA Compliance Coordinator/COI Office 412-383-1735 westbt@upmc.eduwestbt@upmc.edu Lisa M. Schoon, BA Compliance Coordinator/COI Office 412-624-6737 schoonlm@upmc.eduschoonlm@upmc.edu