University of Pittsburgh Industry Relationship Policy (IRP) Presented by Theresa J. Colecchia, JD/Associate General Counsel Pamela J. Grimm, JD/Associate Counsel & VP Legal Affairs David T. Wehrle, CPA, CIA, CFE/Director, COI Office for Division Chiefs/Department of Medicine April 24, 2008

IRP: Specific Activities Covered Gifts and provision of meals Consulting relationships Drug and device samples Site access Support of Continuing Education in the Health Sciences Industry sponsored meetings or Industry support for off-campus meetings Industry support for scholarships or fellowships or other support of students, residents, or trainees Frequent speaker arrangements (Speakers Bureaus) and ghostwriting Other Industry support for research Applies to 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. Effective February 15, 2008

Consulting Contract Guidelines Refer to “Guidelines for Contracting with Outside Industry” in FAQ 7 Must include specific, legitimate tasks and deliverables Payment amount must be commensurate with the tasks performed Must recognize University’s/UPMC’s superior rights to new IP

Review of Consulting Contracts Required actions for your own & your employees’ consulting relationships Copy of consulting contract with company must be provided to: Dr. Steven Shapiro, regardless of amount of remuneration Additionally to Dr. Arthur Levine if annual remuneration >$10,000.

Management Strategies for Consulting Relationships Obtain assurance that all of the faculty member’s consulting activities—taken as a whole—do not constitute a conflict of commitment or exceed one day per week; Obtain assurance that the faculty member will not use any University facilities, funds, or resources in carrying out the consulting; Disclose COI in relevant publications, presentations, abstracts, press releases, and in proposals and applications for research funding.

Management Strategies for Consulting Remuneration >$10,000 Disclosure of SFI on faculty member’s online disclosure form and in protocol submissions to IRB, IBC, IACUC, CORID & ESCRO; Prohibition on faculty member serving as the PI on research of commercial interest to the company, unless further approval is sought; Permission to be co-investigator with the implementation of a management plan.

Industry Sponsored Meetings or Industry Support for Off-Campus Meetings Participation as attendee or speaker is acceptable if Activity is designed to promote evidence-based clinical care and/or advance scientific research; Financial support of Industry is prominently disclosed; Industry does not pay attendee’s travel expenses (Speaker’s reasonable expenses can be reimbursed by Industry)

Industry Sponsored Meetings or Industry Support for Off-Campus Meetings cont’d Attendee does not receive gifts or other compensation for attendance; Meals provided are modest (i.e., the value is comparable to Standard Meal Allowance specified by IRS) and consistent with educational or scientific purpose of event;

Industry Sponsored Meetings or Industry Support for Off-Campus Meetings cont’d SOHS/UPMC speaker must determine all lecture content that reflects a balanced assessment of current science and treatment options; Lecture is not subject to any kind of prior approval by either representatives from Industry or event planners contracted by Industry;

Industry Sponsored Meetings or Industry Support for Off-Campus Meetings cont’d Speakers make clear that views expressed are their own, not those of SOHS/UPMC; Compensation for speaking is limited to a modest honorarium not to exceed $2,500 per event.

Review of Speaking Relationships Speaking relationships are subject to the same review process as consulting contracts.

Contacts Jerome L. Rosenberg, PhD Chair/Conflict of Interest Committee & Research Integrity Officer 412-624-3007; jrosenb@pitt.edu Theresa J. Colecchia 412-624-6281; tjc5@pitt.edu Pamela J. Grimm 412-647-4915; grimmp@upmc.edu David T. Wehrle 412-383-1774; wehrledt@upmc.edu

Questions? COI/IRP Web site: http://www.coi.pitt.edu/IndustryRelation ships/index.htm