1. University of Pittsburgh Presentation to Schools of Pharmacy and Nursing: Consulting Requirements within the Industry Relationship Policy Presented by Theresa J. Colecchia, JD/Associate General Counsel David T. Wehrle, CPA, CIA, CFE/Director, COI Office April 28, 2009

2. Why the Scrutiny of Consultant Agreements? True consulting, where payment is reasonable and related to the services provided, is permitted under the Industry Relationship Policy. Where consulting payments are provided without services being provided, or where rates are out of proportion to the service provided, the payments may be considered kick-backs. Any consulting agreement, under University policy, requires the prior approval of the department chair and/or dean.

3. Inflated Consultant Payments World famous Harvard child psychiatrist earned $1.6 million in consulting fees from drug makers between 2000-2007 and did not report this income to University officials. One colleague reported to have earned at least $1 million. Federal government is investigating. Restrictions or suspension of $287 million in research grants possible. http://www.nytimes.com/2008/06/08/us/08conflict.html?r=l&partn er=rssnyt&emc=rss&oref=slogin

4. Consulting Contract Guidelines A contract covering the proposed services to be provided must be created (i.e., an invitation alone is not sufficient); Faculty member should provide company with “Guidelines for Contracting with Outside Industry” ( see I-R Policy, FAQ # 7); The department chair must review both the substance of the proposed activity, and the terms of the contract, for compliance with the Industry Relationship Policy.

5. Consulting Contract Guidelines There must be a direct correlation between services provided and payment received. Must include specific, legitimate tasks and deliverables. Marketing activities and promotional speaking are not permitted. Use of University resources is not permitted.

6. Consulting Contract Guidelines Any conveyance of rights in intellectual property must be subject to the superior rights of the University, and can only be effective if the University first waives any rights it may have. Note that the University does not assert rights in the copyright to “scholarly works.”

7. Consulting Contract Guidelines University’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.

8. Does agreement provide legitimate tasks and deliverables? Not Acceptable “We will pay you a $4,000 per month retainer for your availability to be on our advisory board as needed. The board will meet as necessary.” Acceptable “We will pay you $250/hr to give advice on prosthetic devices at two 4-hour meetings a year.”

9. Consulting Contract Guidelines Compensation Payment must be commensurate with the task performed; Hourly payment of more than $500 is deemed excessive; Consultant cannot be pre-paid for services.

10. Is payment commensurate with tasks? Not Acceptable “You will receive $5,000 for attending a dinner meeting at “World’s Best Luxury Resort” and providing us with expert advice on new products.” Acceptable “Advisor will speak at a half day meeting on the topic of treatments for bone disease for an honorarium of $1,200 and agrees that this payment is at fair market value.”

11. Speaking Relationships Compensation for speaking is limited to a modest honorarium not to exceed $2,500 per event and reimbursement of reasonable travel expenses; Presentation must be designed to promote evidence-based clinical care and/or to advance scientific research; Speakers must make clear that views expressed are their own, not those of the University;

12. Speaking Relationships 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; Speaker cannot engage in promotional or marketing activities on behalf of the company.

13. Review of Consulting Contracts Provide copy of consulting contract to: Department chair, regardless of amount of remuneration; Additionally to dean, if annual remuneration >$10,000 Consultant should work with COI Office to develop a conflict management plan before contract is submitted to dean for review.

14. 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 work;

15. Management Strategies for Consulting Relationships Faculty member must be excluded from University and UPMC procurement of products from the company; COI must be disclosed in all relevant publications, presentations, abstracts, press releases, and in proposals and applications for research funding.

16. 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 & hSCRO; Prohibition on faculty member serving as the PI on research of commercial interest to the company, unless further approval is sought; Permitted to be a co-investigator with the implementation of a conflict management plan.

17. Contacts Theresa J. Colecchia 412-624-6281; tjc5@pitt.edutjc5@pitt.edu Jerome L. Rosenberg, PhD Chair/COI Committee & Research Integrity Officer 412-624-3007; jrosenb@pitt.edujrosenb@pitt.edu David T. Wehrle 412-383-1774; wehrledt@upmc.eduwehrledt@upmc.edu Khrys X. Myrddin Associate Director, COI Office 412-383-2828; myrddink@upmc.edu myrddink@upmc.edu

18. COI/Industry Relationship Policy Web site: http://www.coi.pitt.edu/IndustryRelationships/index.htm