Conflict of Interest & PHS Regulations for School of Medicine Chairs & Institute Directors

1. Conflict of Interest & PHS Regulations for School of Medicine Chairs & Institute Directors Presented by Jerome L. Rosenberg, PhD/Chair of the COI Committee & David T. Wehrle, CPA, CIA, CFE/Director of the COI Office September 10, 2012

2. Revised Public Health Service (PHS) Regulations • Effective August 24, 2012 • The University of Pittsburgh’s Policy 11-01-03 Conflict of Interest for Faculty, Researchers, Scholars, Research Staff/Coordinators reflects revised PHS regulations

3. Investigator responsibilities • COI training • Investigators currently engaged, or who anticipate engaging in PHS-supported research in the coming year, must complete the CITI (Collaborative Institutional Training Institute) COI Training Module as soon as possible, and before the University can submit a proposal to any PHS agency on which they are listed. • PHS-funded researchers are required to complete the CITI COI Training Module every three years thereafter.

4. Investigator responsibilities cont’d • COI training cont’d • Investigators who do not work on any PHS-funded projects and who: • submit a proposal through the Office of Research for funding from a non-PHS source; or • disclosed outside financial interests on the University’s Faculty/Researcher form; or • have been directed by their department chairs or deans to complete COI training • must complete either the CITI COI Training Module or the Internet-based Studies in Education and Research (ISER) Conflict of Interest Module

5. Investigator responsibilities cont’d • New disclosure requirements: investigators must disclose • outside interests related to their institutional responsibilities exceeding $5,000 (called Significant Financial Interests – SFIs) • income from non-exempt not-for-profit organizations • sponsored/reimbursed travel • new SFIs within 30 days • on the new PHS-specific Faculty/Researcher COI form using the Superform system at https://coi.hs.pitt.edu. This form must be completed as soon as possible and before the University can submit a proposal to any PHS agency on which they are listed.

6. Investigator responsibilities cont’d • Comparing disclosure requirements • Previously: • Investigators disclosed/determined whether their outside interests gave rise to potential conflicts with their research. • Now: • Investigators disclose SFIs related to their institutional responsibilities, and the institution (i.e., supervisors and/or the Conflict of Interest Committee) determines whether they give rise to Financial Conflicts of Interest (FCOIs) with PHS-funded research requiring management.

7. Supervisor responsibilities • Review PHS-specific Faculty/Researcher COI form; • Complete a PHS-specific Management Reporting Form (MRF): • determine whether an SFI in the $5,001-$10,000 range gives rise to an FCOI (i.e., the SFI is related to the PHS-funded research and could directly and significantly affect the design, conduct, or reporting of such research); • if it does not, explain why; or • state that there is an FCOI, indicate how it will be managed, and send a copy of the COI form and MRF to the COI Office

8. Supervisor responsibilities cont’d • If an FCOI has been identified, the conflict management plan (CMP) must include at least the following elements: • Investigator must disclose SFI in abstracts, presentations, press releases, publications resulting from PHS-funded research and in proposals/applications for research funding involving matters of commercial interest to the entity in which the investigator has an SFI • Other students, staff, faculty engaged in the research must be notified of the Investigator’s SFI through the use of a standard notification form • Students must have approval of their department chair or dean to be engaged in project • Other optional management techniques: data steward or oversight committee; prohibiting individual from serving as PI, or other limits on his or her role in the research project.

9. COI Committee (COIC) responsibilities • The COIC, in consultation with department chairs and investigators, will review SFIs greater than $10,000 to determine whether they constitute FCOIs with PHS-funded research. • If they do, the COIC will manage the FCOIs.

10. Monitoring • Supervisors must monitor Investigators’ compliance with management plans on an ongoing basis until completion of the projects, and, for FCOIs, provide the chair of the COI Committee with their plans for monitoring compliance.

11. Public disclosure of FCOIs • In keeping with the PHS’s requirements for greater transparency, before the Institution expends funds on a PHS-funded project, it must publicly post on its COI Web site the following information concerning FCOIs held by the investigator: • Name, title, and role of investigator on the research project • Name of entity in which interest is held • Nature of the SFI • Approximate dollar value of SFI within a defined set of ranges, where possible

12. PHS FCOI Retrospective Reviews • If identification or management of an FCOI was delayed, or the Investigator failed to comply with a plan to manage his or her FCOI, the COIC must complete a retrospective review to determine whether any PHS-funded research was biased in the design, conduct, or reporting of such research performed during the period of non-compliance.

13. For more information/assistance • COI Web site: http://www.coi.pitt.edu/ • Policy 11-01-03: • http://cfo.pitt.edu/policies/documents/policy11-01-03.pdf • Jerome L. Rosenberg: rosenb@pitt.edu; 412-624-3007 • David T. Wehrle: wehrledt@upmc.edu; 412-383-1774 • Khrys X. Myrddin (Associate Director/COI Office): myrddink@upmc.edu; 412-383-2828 • Benjamin T. West (Compliance Coordinator/COI Office): westbt@upmc.edu: 412-383-1735 • Hannelore N. Rogers (Coordinator/COI Office): rogershn@upmc.edu; 412-383-1968 • DHHS Financial Conflict of Interest Web page: http://grants.nih.gov/grants/policy/coi/