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

2. Management of Financial Conflicts of Interest & Revised PHS COI Regulations COI Office David Wehrle, CPA, CIA, CFE/Director Khrys Myrddin, MPPM/Associate Director November 1, 2011

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  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. K. C. Stengel developed a new method for collecting adult stem cells, which was patented by the University; she receives royalties for this IP through Pitt  The technology is licensed to Cell Colonies, Inc., a non-public company  She holds equity in the company  Dr. Stengel is conducting federally sponsored research to further evaluate the technology.

8. 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;

9. Importance of COI Management (cont’d)  University may lose public support and funding for research;  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.

10. THE CHRONICLE of Higher Education Baylor College of Medicine Faces NIH Sanctions Over Financial Conflicts Paul Baskin  Tuesday, January 20, 2010 The NIH has ordered tougher financial disclosures on all grant applications from Baylor College of Medicine, [citing] ”serious concerns” about the college’s compliance with regulations governing conflicts of interest…. The doctors who spoke favorably of Vytorin ® included Christie M. Ballantyne…who collected $34,472 during a five-month period… The NIH informed the institution last month that the agency would impose ‘special award conditions” on all future grants.

11. Today’s topics  University COI Policy  Annual COI filing process  Using the Superform system  University-level COI Management  Research protocols  Entrepreneurial endeavors  Purchasing  Office of Research

12. Today’s topics (cont’d)  Departmental responsibilities  COI Oversight & Management  New PHS Regulations

13. Annual COI Filing Process  University Policies  11-01-03 Conflict of Interest for Faculty, Scholars, Researchers, Research Staff/Coordinators  07-05-02 COI Designated Administrators and Staff  Annual COI memo from the provost & executive vice chancellor

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

15. 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.

16. 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 https://coi.hs.pitt.edu

17. 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.  Dually employed individuals can file Pitt and UPMC forms thru the UPMC system http://compliance.infonet.upmc.com/COI.htm http://compliance.infonet.upmc.com/COI.htm

18. 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

19. Who Has Access to the COI Database? (cont’d)  Research administrators can determine whether investigators have a current COI form on file  Request access to the database 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 rogershn@upmc.edu

20. University-level COI Management— Research Protocols  The COIC is responsible for managing potential conflicts involving the following:  Human subject research (IRB)  Animal research (IACUC)  Committee for Oversight of Research and Clinical Training Involving Decedents (CORID)  Recombinant DNA research (IBC)  Human stem cell research (hSCRO)

21.  COI questions that appear on protocol applications apply to all investigators and research personnel  PI is responsible for ensuring that all investigators and study personnel are asked these questions  Reporting must be kept current  Whenever new outside interests are accrued, investigators 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 University-level COI Management — Research Protocols (cont’d)

22. 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 publicly-traded 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)possess any equity interest in the non-publicly- traded entity that either sponsors this research or owns the technology being evaluated?

23. COI Questions on Protocols (cont’d) c)receive salary, consulting fees, honoraria, royalties or other payments from the entity that either sponsors this research or owns the technology being evaluated that is expected to exceed $10,000 in any twelve- month period? d)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? e)have a financial relationship with a Licensed Start-up Company (which is being monitored by the COI Committee) that has an option or license to utilize the technology being evaluated?

24.  IRB only f)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. COI Questions on Protocols (cont’d)

25.  Answering “Yes” to any of the COI questions on the IRB protocol requires use of the Standard COI Management Plan (SMP) for Human Subject Research  Available in OSIRIS or from the forms page of the COI Office Web site: http://www.coi.pitt.edu/COIforms.htm http://www.coi.pitt.edu/COIforms.htm University COI Management—Research Protocols University COI Management—Research Protocols (cont’d)

26.  For IACUC, CORID, and hSCRO, investigator cannot be PI if s/he answers “Yes” to the questions asking about equity, remuneration, or a relationship with a Licensed 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. University-level COI Management —Research Protocols

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

28. 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 companies in which University employees have a financial interest

29. 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  If yes, referred to COI Office for review & management

30. 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

31. Departmental COI Management (cont’d)  Department Chairs are responsible for the development of COI management plans for research not overseen by a regulatory committee  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

32. Departmental COI Management (cont’d)  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

33. Proper use of students/staff by faculty members w/ outside interests  Prospective review and approval of activities by department chair or dean  Formal notification of faculty members’ interest in outside companies  Faculty members should distribute Student/Staff Notification Form for signature by students/staff  Students/staff should discuss any concerns with faculty members’ non-conflicted supervisors and/or COI Committee

34. Departmental COI Management – Management Reporting Form  Completed by academic supervisor (department chair or dean) only for University Faculty/Researcher form  Documents ALL actions taken to manage COIs related to disclosed financial relationships  If no COI, it documents that relationship was reviewed and there is no overlap with University responsibilities

35. Departmental COI Management – Designated Administrator/Staff  Supervisor reviews Designated Administrator/Staff disclosures to determine if there is any overlap between outside interests and the individual’s University responsibilities  Supervisor documents the plan to manage any potential COI in the form of a memorandum (do not use the MRF) that is kept on file by the department.

36. Industry Relationship & Outside Employment Policies  http://www.coi.pitt.edu/IndustryRelationships/policy.htm http://www.coi.pitt.edu/IndustryRelationships/policy.htm  http://www.cfo.pitt.edu/policies/policy/02/02-06-01.html http://www.cfo.pitt.edu/policies/policy/02/02-06-01.html

37. Outside Engagements with Industry — What is Allowed? True consulting, where payment is reasonable and related to the services provided, is permitted under the Industry Relationship Policy (IRP).True consulting, where payment is reasonable and related to the services provided, is permitted under the Industry Relationship Policy (IRP). Where consulting payments are made without services being provided, or where payment rates are out of proportion to the service provided, the payments may be considered kick-backs.Where consulting payments are made without services being provided, or where payment rates are out of proportion to the service provided, the payments may be considered kick-backs. Any consulting agreement, under University/UPMC policies, requires the prior approval of the department chair and/or dean.Any consulting agreement, under University/UPMC policies, requires the prior approval of the department chair and/or dean.

38. Consulting Contract Guidelines  A contract detailing the proposed services to be provided must be in writing;  Faculty member should provide company with “Guidelines for Contracting with Outside Industry” (see IRP, FAQ # 7);  Consultant cannot engage in promotional or marketing activities on behalf of the company;  How do you know if it is promotional?  Is it organized by the Marketing Dept. or the R & D Dept.?  Who invites the attendees?  Who controls the content?

39. Consulting Contract Guidelines (cont’d)  University’s/UPMC’s name and address cannot appear in the contract; consultant’s personal address must be used instead;  Any non-compete clause in the contract cannot interfere with faculty member’s duties at the University/UPMC;  Use of University/UPMC resources is not permitted;  Use of Consulting Addendum helps ensure that contract terms will comply with IRP (see the Policy Compliance Tools tab within the IRP Web pages on the COI Web site).

40. Consulting Contract Guidelines (cont’d)  Compensation  There must be a direct correlation between services provided and payment received.  Contract must include specific, legitimate tasks and deliverables. …

41. Consulting Contract Guidelines (cont’d)  Payment must be commensurate with the task performed;  Hourly payment of more than $500 is deemed excessive;  Consultant cannot be pre-paid for services.

42. Speaking Contract Guidelines  A contract detailing the proposed services to be provided must be in writing (e.g., an e-mail invitation is not sufficient);  The Speaker’s Agreement Addendum helps ensure that contract terms will comply with provisions of the IRP (see the Policy Compliance Tools tab within the IRP Web pages of the COI Web site); IRP (see the Policy Compliance Tools tab within the IRP Web pages of the COI Web site);  Compensation for speaking is limited to a modest honorarium not to exceed $2,500 per event, and reimbursement of reasonable travel expenses;

43. Speaking Guidelines (cont’d)  Presentation must be designed to promote evidence-based clinical care and/or to advance scientific research;  Marketing activities and promotional speaking are not permitted;  Speakers must make clear that views expressed are their own, not those of the University/UPMC;

44. Speaking Guidelines (cont’d)  Speaker must control content of presentation, and content cannot be subject to company’s approval;  Content must reflect a balanced assessment of current science and treatment options and cannot focus on a single company’s product.

45. New NIH COI Regulations  Released August 24, 2011  Major changes  Lowered reporting threshold to $5,000 (from $10,000)  Institution is now charged with determining if an investigator’s financial interests give rise to a COI

46. New NIH COI Regulations (cont’d)  Mandatory COI training, renewed every 4 years  Public disclosure of managed conflicts on website or must respond to inquiries within five days  Institutions must disclose managed COIs at time of award, annually, and within 30 days of identifying a new COI  Institution must report details of financial relationship and how the COI was managed  Institution must monitor investigator compliance during the period of the award.

47. New NIH COI Regulations (cont’d)  COIC has established subcommittee to review the new requirements and propose changes to University policy  University must be in full compliance by August 25, 2012

48. Additional Help with COI Management  Conflict of Interest Office  COI Office Web site 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

49. Questions?

50. Contacts/Assistance  Jerome L. Rosenberg, PhD Chair/COI Committee 412-624-3007 jrosenb@pitt.edu 412-624-3007 jrosenb@pitt.edu jrosenb@pitt.edu  David T. Wehrle, CPA, CFE, CIA Director/COI Office 412-383-1774 wehrledt@upmc.edu wehrledt@upmc.edu  Khrys X. Myrddin, MPPM Associate Director/COI Office 412-383-2828 myrddink@upmc.edu myrddink@upmc.edu  Hannelore N. Rogers, MA Coordinator/COI Office 412-383-1968 rogershn@upmc.edu rogershn@upmc.edu  COI Web site: www.coi.pitt.edu www.coi.pitt.edu