Guidance on Implementation of Industry Relationship Policy

For faculty in the Schools of the Health Sciences with consulting contracts that provide income of more than $10,000 annually.

MEMORANDUM

TO: Schools of the Health Sciences Deans
School of Medicine Department Chairs
FROM: Arthur S. Levine, M.D.
DATE: March 20, 2008
RE: Guidance on Implementation of Industry Relationship Policy

As the UPMC and University Schools of the Health Sciences Industry Relationships Policy (“Policy”) takes effect, I want to thank all of you for your diligent efforts to ensure compliance. I also want to provide you with further guidance on one aspect of the Policy, Section C.2, which requires prior approval by the dean of consulting arrangements for faculty in excess of Ten Thousand Dollars ($10,000) per year. While the Policy has a comprehensive set of guidelines designed to ensure that consulting contracts are not gifts in disguise, when I review consulting above the Ten Thousand Dollar ($10,000) limit, I have other concerns in mind. This dollar amount constitutes a significant financial interest (“SFI”) under the PHS regulations. See 405/10/12

Before you send any proposed consulting agreement involving an SFI to me for approval, you should be prepared to provide me assurance that all of the faculty member’s consulting activities, taken as a whole, do not present a conflict of commitment, and that all consulting will not exceed one day per week. You must also ascertain if the SFI may affect any federally funded research activities of the faculty member. I will expect you as the dean or department chair to have proposed an appropriate management plan that you believe will adequately manage, reduce or eliminate any potential conflict of interest created by the SFI. While the elements may vary, depending on the nature of the potential conflict, at a minimum, the proposed plan should include: 1) disclosure of the SFI on the faculty member’s online conflict disclosure form, and in all grant applications, publications, public presentations, and IRB, IBC and IACUC submissions, 2) a prohibition on the faculty member serving as the principal investigator on sponsored research from the company in which he/she has an SFI, unless further approval is sought, and 3) assurance that the faculty member will not use any University facilities, funds or resources in carrying out the consulting. You may utilize the services of the University’s Conflict of Interest Office in crafting an appropriate plan.

I will also request that, when forwarding your own consulting agreements to me for review, you will similarly work with the Conflict of Interest Office to propose a conflict of interest management plan. Review of the actual consulting agreement itself for compliance with the Policy will follow the procedure as set forth in the FAQ on guidelines for consulting. Thank you for your continued dedication to ensuring the responsible conduct of research at the University