1. Outside Consulting Relationships: Compliance Review & COI Management Khrys X. Myrddin, MPPM Associate Director, COI Office, University of Pittsburgh

2. Disclaimers  This presentation covers the review of consulting contracts based on current University policies and procedures.  Policy Review Committee  https://www.policyreview.pitt.edu/ https://www.policyreview.pitt.edu/  Timetable  March – July 2016: Review and approval process through the required shared governance committees  Late Summer 2016: Finalized policies on patents, copyright, and conflict of interest will be available  Consulting agreements are reviewed solely for compliance with University of Pittsburgh/UPMC policies.  No additional legal review or analysis is performed for any other purpose. University/UPMC personnel should seek advice from a personal attorney regarding issues not related to compliance with University/UPMC policies  University COI Office staff are not attorneys and are not authorized to speak to outside counsel.

3. Relevant University Policies

4. Policy 02-06-01 Outside Employment The University recognizes the obligation to make the special knowledge and intellectual competence of its faculty members available to government, business, labor, and civic organizations; as well as the potential value to the faculty member and the University.

5. Policy 02-06-01 Outside Employment  Permission from the department chairman, dean or campus president is required.  No use of University name, resources, facilities or staff.  Time given to outside activities is not to exceed one day per week.  Fees for outside work are to be commensurate with the faculty member's professional standing.

6. Policy 11-01-03 COI for Faculty, Scholars, Researchers, Research Staff/Coordinators  Requires disclosure of outside interests upon appointment, annually before April 15 th, and whenever outside interests change  Outlines department responsibilities for reviewing outside interests and managing COIs  Outlines central review processes and COI management related to:  Specifically regulated research (HRPO, IACUC)  PHS COI review process  Licensed Start-up Companies (LSCs)

7. Industry Relationships Policy (IRP)  Policy on Conflicts of Interest and Interactions between Representatives of Certain Industries and Faculty, Staff and Students of the Schools of the Health Sciences and Personnel Employed by UPMC at all Domestic Locations  Implemented in February 2008  Applies to SOHS, but also contains “best practices” that are used across the University

8. Industry Relationships Policy (IRP)  C.2 Consulting Relationships  Scope of work must describe specific tasks and deliverables  Payments must be tied to deliverables  Payments must be commensurate with tasks assigned  Prior permission of division chief (as applicable), department chair, and/ or dean (as applicable) is required

9. Industry Relationships Policy (IRP)  C.2 Consulting Relationships  Approval of Dean and SVC-HS required for agreements that provide compensation:  In the form of equity in a nonpublic company  Cash in excess of $10,000 in a 12-month period  Cash and equity that exceeds $10,000 in value in a 12-month period in a publicly-traded company  COI Office must develop a COI Management Plan (CMP)

10. Industry Relationships Policy (IRP)  C.6 Industry Sponsored Meetings or Industry Support for Off-Campus Meetings  SOHS personnel or students may participate in or attend such meetings, so long as:  (a) activity is designed to promote evidence-based clinical care and/or advance scientific research  (b) financial support of Industry is prominently disclosed  (c) Industry does not pay attendees’ travel and attendance expenses  (d) attendees do not receive gifts or other compensation for attendance  (e) meals provided are modest

11. Industry Relationships Policy (IRP)  C.6 Industry Sponsored Meetings or Industry Support for Off-Campus Meetings  If SOHS/UPMC personnel or students are speakers at such events:  (a) all lecture content is determined by the SOHS/UPMC speaker and reflects a balanced assessment of the current science and treatment options  speaker makes clear that the views expressed are the views of the speaker and not the SOHS or UPMC;  (b) compensation is limited to reimbursement of reasonable travel expenses and a modest honorarium not to exceed $2,500 per event.

12. Industry Relationships Policy (IRP)  C.8 Speakers Bureaus & Ghostwriting  Event must meet criteria of C.6  May NOT attend or participate in events if:  Industry provides the lecture or presentation content or it is subject to any form of prior approval by company;  the content of the presentation is not based on the best available scientific evidence;  the company selects the individuals who may attend or provides any honorarium or gifts to the attendees.  Cannot be listed as co-authors on papers ghostwritten by Industry representatives.  Should meet International Committee of Medical Journal Editors (ICMJE) criteria for authorship

13. Process

14. Prospective approval of supervisor  Consultant secures approval “in principle” of his/her supervisor(s) (division chief, department chair, or dean; sometimes also center director) to engage in the outside activity

15. Compliance Review  Pitt-only faculty, staff, students  Department responsible for compliance review  COI Office can assist  Dually-employed (Pitt/UPP) and UPP/UPMC-only personnel  Submit contract and Approval form to UPMC Office of Ethics & Compliance COI_Consulting@upmc.eduCOI_Consulting@upmc.edu  Approval Form available on Policy Compliance Tools page  http://www.coi.pitt.edu/IndustryRelationships/PolicyTools/IndustryCon sultingApprovalForm.pdf http://www.coi.pitt.edu/IndustryRelationships/PolicyTools/IndustryCon sultingApprovalForm.pdf

16. Compliance Review – Policy Compliance Tools  http://www.coi.pitt.edu/IndustryRelationships/PolicyTools.htm http://www.coi.pitt.edu/IndustryRelationships/PolicyTools.htm  Industry Relationship Policy Guidance document  Addenda  May not be revised  Will not address all issues with all contracts

17. Compliance Review – Main Issues  Appropriate activities  May not engage in sales, marketing, or other promotional activities  May not engage in research as a consultant  Does the activity require use of University equipment, facilities, or specialized software under educational/nonprofit license?  Compensation  Tied to deliverables  Hourly rate (cash or stock options per hour of service or meeting) or project-based payment  Cannot exceed $500/hour or $2500 honorarium for speaking

18. Compliance Review – Main Issues  Intellectual Property (IP)  11-02-01: Patent Rights and Technology Transfer 11-02-01  11-02-02: Copyrights 11-02-02  Personal consulting agreements cannot assign new IP developed by a University or UPMC employee to the company without an appropriate qualification that assignment is subject to any superior rights the University and/or UPMC may have  Unless University and/or UPMC waive such rights in writing

19. Compliance Review – Main Issues  Intellectual Property  Company accepts University/UPMC IP language  Company representative speaks with University representative from OTM or OGC or UPMC attorney regarding the scope and application of Pitt/UPMC IP policies  IP Waiver  Form available on Office of Research Forms page  Submit completed form signed by Chair and otherwise compliant agreement  Inform COIO/UPMC COI Analyst if approved

20. Compliance Review – Main Issues  Company will prohibit consultant from publishing anything related to the company without prior approval  Limit to only services provided under the agreement  Nothing contained herein shall give Company any rights to review draft publications by Consultant of work arising from or related to his/her employment at the University of Pittsburgh.  Non-compete language  Nothing in this agreement should be interpreted to restrict Consultant’s work at the University of Pittsburgh and UPMC, including engaging in research activities sponsored by any company.

21. Compliance Review – Main Issues  Confidential Information: If defined to include the contract itself or work generated by Consultant thereunder, then add language permitting Consultant to disclose pertinent information to University/UPMC

22. Department PHS COI Review  For contracts with remuneration that may exceed $5,000, but not $10,000 in a 12-month period, the dept. (or division in DOM) is responsible for the COI review.  Guidance document: http://www.coi.pitt.edu/PHS/PHSReviewofConsultingContracts.pdf

23. COI Management Plan (CMP)  COIO must develop a CMP if consultant will be paid  In equity (stock, stock options, warrants, etc.) in a nonpublic company  Cash in excess of $10,000 in a 12-month period  Cash and equity that exceeds $10,000 in value in a 12-month period in a publicly-traded company  CMP and contract must be approved by division chief (if applicable), chair, dean, and SVC-HS

24. COI Management Plan (CMP)  PHS COI Review, if applicable  Engaged in any research that is:  Sponsored by the company; or  Evaluating its products, services, or intellectual property?  Management of any existing research COIs included in overall CMP

25. COI Management Plan (CMP)  Prospective approval of Dean and SVC-HS  CMP for specific research projects  Guidance for future projects sponsored by or of commercial interest to company  Guidance regarding review of new PHS-funded research activities  Updating University and UPMC COI disclosure forms  Disclosure of SFI in any relevant publications, presentations, abstracts, and press releases  Disclosure of SFI in proposals and applications for research funding of commercial interest to the company

26. COI Management Plan (CMP)  Recusal from purchasing decisions involving the company’s products or services  No use of University or UPMC facilities, funds or resources in performing consulting work for the company  Total time expenditure on all outside professional activities cannot exceed one day per week on the average

27. Compensation caps  Completely OPTIONAL  $5,000/12-months  Only relevant for PHS-funded investigators  Not reportable SFI (University), no COI review required  (NB: will still need to disclose on UPMC form)  $10,000/12-months  Avoid PI-exclusion rule for human subject and animal research sponsored by or of commercial interest to company  Only need approval of direct supervisor  COIO does not need to develop CMP  NB: Department responsible for PHS COI review, if applicable

28. Dean/SVC-HS Approval  Direct supervisor(s) approved activity  Terms of the contract are compliant with University and UPMC policies  IP waiver has been approved, if applicable  Individual has agreed to CMP  Department Chair forwards email chain and contract to Dean (if not Dean of SOM, then Dean forwards to Dr. Levine)  Once Dr. Levine responds with his approval, Consultant may execute agreement

29. Subsequent Review

30. Renewals, change of SOW, compensation  Renewals: If no changes to agreement, report to supervisor that you are continuing the relationship  Continue to disclose relationship on COI form and in research protocols, CRAs, etc.  Continue to abide by CMP, if applicable  Changes to terms > compliance review  Changes to SOW > approval of supervisor and notify COIO  Changes in compensation > approval of supervisor, contact COIO for COI review

31. Licensed Start-up Companies

32.  Nonpublic, option/license to University IP, University and/or its employees or students have equity  Subject to special oversight by COIC  All consulting relationships between University personnel and students with LSCs must be approved by the University’s COI Committee  Compensated/uncompensated  Regardless of whether individual is inventor of optioned/licensed IP or an equity holder/company founder  In addition to applicable normal review process

33. Resources

34.  COI website: http://www.coi.pitt.edu/index.htmhttp://www.coi.pitt.edu/index.htm  Industry Relationships Policy  http://www.coi.pitt.edu/IndustryRelationships/index.htm http://www.coi.pitt.edu/IndustryRelationships/index.htm  COI Office: http://www.coi.pitt.edu/COIOffice.htmhttp://www.coi.pitt.edu/COIOffice.htm  David T. Wehrle, CPA, CIA, CFE Director 412-383-1774; dtw12@pitt.edu  Khrys X. Myrddin, MPPM Associate Director 412-383-2828; kxm1@pitt.edu  UPMC for COI questions and issues: conflicts@upmc.educonflicts@upmc.edu