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University of Pittsburgh
Presentation to Department of Family Medicine
Outside Engagements within the Industry Relationship Policy
February 8, 2010Barbara Barnes, MD Pamela Grimm, JD
Recent Developments re: Reporting of Outside Interests
Pharmaceutical companies have begun posting on their Web sites payments made to speakers and consultants
Enables entities like the University of Pittsburgh/UPMC to review and monitor outside interests of employees for compliance with the Industry Relationship Policy
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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).
• 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.
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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?
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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.
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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. …
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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.
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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; Compensation for speaking is limited to a
modest honorarium not to exceed $2,500 per event, and reimbursement of reasonable travel expenses;
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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;
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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.
Conflict Management Plan
Dean Levine’s approval and a COI management plan are needed if compensation exceeds $10,000 in any 12-month
period, or options or equity exceed 5%
ownership interest or $10,000
Conflict Management Plan cont’d
Will not be permitted to serve as PI on research of commercial interest to the company
Can serve as a Co-investigator, but role in the study must be diluted
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Contacts
Barbara Barnes, MD
412-647-8212; [email protected] Pamela Grimm, JD
412-647-4915; [email protected] David T. Wehrle, CPA, CIA, CFE412-383-1774; [email protected]
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For more information…
On the University’s COI Web site:COI/Industry Relationship Policy pages:http://www.coi.pitt.edu/IndustryRelationships/index.htm