Conflict of Interest Office A partner in promoting integrity in research, teaching, and administration

Annual COI Disclosures Khrys X. Myrddin, MPPM, Associate Director Benjamin T. West, Compliance Coordinator University of Pittsburgh Conflict of Interest Office

Definitions Annual COI Filing Season University of Pittsburgh COI Disclosure Forms COI Training Requirements PHS Update Todays Topics

Any individual, regardless of title or position, who participates in the design, conduct, or reporting of research Based on individuals role in the research Includes faculty, staff, and students Definitions - Investigator

Administration for Children and Families (ACF) Administration on Children, Youth and Families (ACYF) Administration for Community Living (ACL) Agency for Healthcare Research and Quality (AHRQ) Centers for Disease Control and Prevention (CDC) Centers for Medicare & Medicaid Services (CMS) Food and Drug Administration (FDA) Health Resources and Services Administration (HRSA) Indian Health Service (IHS) National Institutes of Health (NIH) National Cancer Institute Substance Abuse and Mental Health Services Administration (SAMHSA) Agencies of the Public Health Service (PHS)

The PI, project director, and any other person, regardless of title or position, who is responsible for the design, conduct, or reporting of research that is funded in whole or in part by any agency of the PHS, including collaborators and consultants. Based on individuals role in the research Covers all persons (faculty, staff, and students) engaged in the project, not just those listed on the grant/contract Definitions – PHS-funded Investigator

A financial interest that reasonably appears to be related to the Investigators Institutional Responsibilities Different reporting thresholds for PHS-funded projects Questions on regular and PHS Faculty/Researcher COI forms reflect the definition thresholds COI questions on IRB and IACUC protocols ask about such interests related to the particular project Definitions – Significant Financial Interest (SFI)

An Investigators professional responsibilities on behalf of the University of Pittsburgh, including activities such as research teaching professional practice institutional committee memberships service on panels such as IRBs or DSMBs other administrative activities Definitions – Institutional Responsibilities

Equity in a publicly-traded entity that exceeds $10,000 in value or 5% Any amount of equity in a non-publicly traded entity Remuneration from an entity that exceeds $10,000 in a 12 month period (excl. non-profit & govt agencies) Being the author or inventor of a technology that has been patented, copyrighted, or optioned/licensed to an external entity, and on which evaluative or developmental research is continuing; Definitions – SFI (cont.)

Aggregated remuneration from and equity in any publicly traded entity exceeding $5,000 in value or an equity interest that exceeds 5% in such an entity; Remuneration from a non-publicly traded entity (including nonprofit entities except Exempt Institutions) in a 12 month period exceeding $5,000, or any equity interest in such an entity; Reimbursed or sponsored travel expenses related to Institutional Responsibilities from a single entity (except Exempt Institutions) that exceeds $5,000 in 12-months Definitions – PHS SFI

A federal, state, or local government agency; A domestic Institution of Higher Education; An academic teaching hospital; A medical center; or A research institute that is affiliated with an Institution of higher education Definitions – Exempt Institutions

A Significant Financial Interest related to a research project that could directly and significantly affect the design, conduct, or reporting of the research. Definitions – Financial Conflict of Interest (FCOI)

Everyone files between Jan 1 st – April 15 th Disclosures must be kept up-to-date throughout the year Separate UPMC & Pitt COI systems University: Superform UPMC: My Hub > Human Resources tab > COI Annual COI Filing

All regular full-time faculty Anyone, regardless of title or position, who engages in research at the University of Pittsburgh Anyone who is or expects to be an investigator on a PHS-funded project must complete the PHS Faculty/Researcher form, instead of the regular form Only complete the Faculty/Researcher form that applies to you, not both Annual COI Filing – Faculty/Researcher forms

Part-time and adjunct faculty members not engaged in research and with no financial interests that would give rise to potential or perceived conflicts of interest with their University responsibilities do not need to complete a form Unless instructed to do so by their department chair. Faculty on unpaid leave do not need to complete COI disclosure forms until they return to the University Annual COI Filing – Faculty/Researcher forms

For identifying COIs related to purchasing Faculty who are in a position to make, direct, or materially influence University business decisions need to complete a Designated Administrator/Staff form, regardless of whether or not they complete a Faculty/Researcher form Anyone who has significant influence over the selection of outside vendors or providers of services (e.g., can approve a Directed/Sole Source form) All deans, department chairs, center directors Annual COI Filing – Designated Administrator/Staff form

NO PHS-funded research: ISER COI Module Must retake if completed before August 6, 2012 CITI Training will also fulfill this requirement PHS-funded Investigators: CITI COI Training Module Office of Research checks for this prior to submitting proposals to PHS agencies Access through ISER training does NOT fulfill this requirement COI Training requirements

Q4 – Reimbursed or Sponsored Travel now has $5,000 reporting threshold From a single organization in a 12 month period for a single trip or series of trips Includes members of your immediate family/household New COI questions on PHS-funded IRB & IACUC protocols COI questions removed from rDNA/IBC, CORID, & hSCRO PHS Updates

QUESTIONS?

COI Website: COI Office Staff David T. Wehrle: Khrys X. Myrddin: Benjamin T. West: COIC Chair Jerome L. Rosenberg: Information & Assistance